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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65572

37 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 12, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ortho-Clinical Diagnostics

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

37 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 37

VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0292-2014
Recall number
Z-0292-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
16732 units (12208 units domestically & 4524 internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 2 of 37

VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0293-2014
Recall number
Z-0293-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
544 units (48 domestically & 496 internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 3 of 37

VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0294-2014
Recall number
Z-0294-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
16583 units (3073 domestically & 13510 internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 4 of 37

VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0295-2014
Recall number
Z-0295-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
28501 units (20321 domestically & 8180 internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 5 of 37

VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0296-2014
Recall number
Z-0296-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
183267 units (89415 units domestically & 93852 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 6 of 37

VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0297-2014
Recall number
Z-0297-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
24322 units (12329 units domestically & 11993 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 7 of 37

VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0298-2014
Recall number
Z-0298-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
70,125 units (20,219 units domestically & 49,906 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 8 of 37

VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System

Z-0299-2014
Recall number
Z-0299-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
197,552 units (88,537 units domestically & 109,015 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 9 of 37

VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0300-2014
Recall number
Z-0300-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
74,792 units (35,501 units domestically & 60,291 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 10 of 37

VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0301-2014
Recall number
Z-0301-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
31,0947 units (139,602 units domestically & 171,345 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 11 of 37

VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0302-2014
Recall number
Z-0302-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
231,112 units (133,173 units domestically & 97,939 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 12 of 37

VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0303-2014
Recall number
Z-0303-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
11,135 units (153 units domestically & 10,982 internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 13 of 37

VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0304-2014
Recall number
Z-0304-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
28,855 units (12,472 units domestically & 16,383 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 14 of 37

VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0305-2014
Recall number
Z-0305-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
86,503 units (30,378 units domestically & 56,125 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 15 of 37

VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0306-2014
Recall number
Z-0306-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
28,739 units (480 units domestically & 32,739 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 16 of 37

VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382

Z-0307-2014
Recall number
Z-0307-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
12,484 units (9,040 units domestically & 3,444 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 17 of 37

VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0308-2014
Recall number
Z-0308-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
364,752 units (148,285 units domestically & 216,467 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 18 of 37

VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0309-2014
Recall number
Z-0309-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
86,522 units (30,717 units domestically & 55,805 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 19 of 37

VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0310-2014
Recall number
Z-0310-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
24,857 units (17,887 units domestically & 6970 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 20 of 37

VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0311-2014
Recall number
Z-0311-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
100.393 units (36,873 units domestically & 63,520 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 21 of 37

VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0312-2014
Recall number
Z-0312-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
205,534 units (137,887 units domestically & 67,647 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 22 of 37

VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0313-2014
Recall number
Z-0313-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
37,525 units (11,898 units domestically & 25,627 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 23 of 37

VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0314-2014
Recall number
Z-0314-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
349,072 units (142,455 units domestically & 205,617 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 24 of 37

VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0315-2014
Recall number
Z-0315-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
28,633 units (14,634 units domestically & 13,999 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 25 of 37

VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0316-2014
Recall number
Z-0316-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
62,039 units (5,974 units domestically & 4,702 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 26 of 37

VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0317-2014
Recall number
Z-0317-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
62,039 units (26,765 units domestically & 35,274 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 27 of 37

VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0318-2014
Recall number
Z-0318-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
101,976 units (39,909 units domestically & 62,067 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 28 of 37

VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0319-2014
Recall number
Z-0319-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
6,606 units (5,071 units domestically & 1,535 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 29 of 37

VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0320-2014
Recall number
Z-0320-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
81,382 units (28,256 units domestically & 53,126 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 30 of 37

VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0321-2014
Recall number
Z-0321-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
21,163 units (16,218 units domestically & 4,945 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 31 of 37

VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0322-2014
Recall number
Z-0322-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
19,438 units (8,845 units domestically & 10,593 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 32 of 37

VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0323-2014
Recall number
Z-0323-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
15,492 units (11,870 units domestically & 3,622 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 33 of 37

VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0324-2014
Recall number
Z-0324-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
175,689 units (86,745 units domestically & 88,944 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 34 of 37

VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0325-2014
Recall number
Z-0325-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
7,926 units (6,026 units domestically & 1,900 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 35 of 37

VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0326-2014
Recall number
Z-0326-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
127,662 units (42,487 units domestically & 84,906 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 36 of 37

VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0327-2014
Recall number
Z-0327-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
31,395 units (10,864 units domestically & 20,531 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.

device · product 37 of 37

VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0328-2014
Recall number
Z-0328-2014
Initiated
June 12, 2013
Classification
Class II
Status
Terminated
Quantity
85,646 units (13,640 units domestically & 72,006 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Code information

Multiple lots affected, with expiry dates through 22-Mar-2015

Distribution pattern

Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.