Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative dete

Recalled September 18, 2013 · FDA recall Z-2171-2013 · Siemens Healthcare Diagnostics

Hazard

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

Units

488

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 (500 tests), REF SMN 10331250, Cat No. 00203473 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 →