ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Reported: June 12, 2013 Initiated: May 14, 2013 #Z-1514-2013
Product Description
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Reason for Recall
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 99 (2 pk)
- Distribution
- Nationwide Distribution.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 99 (2 pk).
Why was this product recalled? ▼
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1514-2013.
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