Device 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.
Z-2171-2013
Product summary
- Event
- Event 65806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 488
- Official record key
device-enforcement:Z-2171-2013
Official wording
Reason: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Code information: 22298218
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
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.