Device product
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Z-1514-2013
Product summary
- Event
- Event 65224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 (2 pk)
- Official record key
device-enforcement:Z-1514-2013
Official wording
Reason: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information: Calibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability