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Recall Observatory FDA recall evidence

Device product

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

June 12, 2013

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 65572
Status
Terminated
Classification
Class II
Quantity
31,0947 units (139,602 units domestically & 171,345 units internationally)
Official record key
device-enforcement:Z-0301-2014

Official wording

Reason: 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.

Derived failure modes

  • 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.