Device product
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Z-1119-2013
Product summary
- Event
- Event 64610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3871
- Official record key
device-enforcement:Z-1119-2013
Official wording
Reason: Negative bias in patient samples for Vitamin D
Code information: Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Negative bias in patient samples for Vitamin D