Device product
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Z-1512-2013
Product summary
- Event
- Event 65224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 309 (100 test) kits
- Official record key
device-enforcement:Z-1512-2013
Official wording
Reason: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information: Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability