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.
Reported: September 18, 2013 Initiated: July 25, 2013 #Z-2172-2013
Product Description
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.
Reason for Recall
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 44
- Distribution
- 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.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 44.
Why was this product recalled? ▼
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2013. Severity: Moderate. Recall number: Z-2172-2013.
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