FDA-Device2013-09-18Class II
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.
Siemens Healthcare Diagnostics, Inc
Hazard
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Sold states
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.
Affected count
488
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2171-2013Don't want to check this manually?
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