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Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determi
Recalled September 18, 2013 · FDA recall Z-2169-2013 · Siemens Healthcare Diagnostics
Hazard
Calibration failures and/or significant negative shifts in quality control (QC) and patient results. · FDA Class II
Units
3114
Sold at
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.
Description
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →