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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65806

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

Open FDA event record

Event summary

Timeline bucket
July 25, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, Inc

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

4 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 4

ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Z-2169-2013
Recall number
Z-2169-2013
Initiated
July 25, 2013
Classification
Class II
Status
Terminated
Quantity
3114

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Code information

22288218, 22296218, 222907218

Distribution pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.

device · product 2 of 4

ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Z-2170-2013
Recall number
Z-2170-2013
Initiated
July 25, 2013
Classification
Class II
Status
Terminated
Quantity
2840

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Code information

22289218, 22297218, 22535218

Distribution pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.

device · product 3 of 4

ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Z-2171-2013
Recall number
Z-2171-2013
Initiated
July 25, 2013
Classification
Class II
Status
Terminated
Quantity
488

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Code information

22298218

Distribution pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.

device · product 4 of 4

ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Z-2172-2013
Recall number
Z-2172-2013
Initiated
July 25, 2013
Classification
Class II
Status
Terminated
Quantity
44

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Code information

22299218

Distribution pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada and Mexico.