Device product
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
Z-1121-2013
Product summary
- Event
- Event 64610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 372 pk Cals
- Official record key
device-enforcement:Z-1121-2013
Official wording
Reason: Negative bias in patient samples for Vitamin D
Code information: Lot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Negative bias in patient samples for Vitamin D