Device product
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Z-1120-2013
Product summary
- Event
- Event 64610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4133
- Official record key
device-enforcement:Z-1120-2013
Official wording
Reason: Negative bias in patient samples for Vitamin D
Code information: Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Negative bias in patient samples for Vitamin D