Device 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.
Z-2169-2013
Product summary
- Event
- Event 65806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3114
- Official record key
device-enforcement:Z-2169-2013
Official wording
Reason: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Code information: 22288218, 22296218, 222907218
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.