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Recall Observatory FDA recall evidence

Device product

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

July 25, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 65806
Status
Terminated
Classification
Class II
Quantity
44
Official record key
device-enforcement:Z-2172-2013

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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