ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Reported: June 12, 2013 Initiated: May 14, 2013 #Z-1512-2013
Product Description
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
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
- 309 (100 test) kits
- Distribution
- Nationwide Distribution.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 309 (100 test) kits.
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-1512-2013.
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