FDAFDA · Food and drugs·Recall number Z-1514-2013
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Published June 12, 2013 · Recall initiated: May 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- Nationwide Distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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