Device product
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Z-1513-2013
Product summary
- Event
- Event 65224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3302 Kits (500 test)
- Official record key
device-enforcement:Z-1513-2013
Official wording
Reason: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Code information: Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability