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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.

Z-1515-2013

May 14, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 65224
Status
Terminated
Classification
Class II
Quantity
198 (6 pk)
Official record key
device-enforcement:Z-1515-2013

Official wording

Reason: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Code information: Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability