ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Reported: November 13, 2013 Initiated: August 16, 2013 #Z-0173-2014
Product Description
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Reason for Recall
PTH Calibrator packaged with only high calibrator.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 595 kits total (5 kits with packaging error)
- Distribution
- Nationwide Distribution including MD, PA, and CT.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 595 kits total (5 kits with packaging error).
Why was this product recalled? ▼
PTH Calibrator packaged with only high calibrator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2013. Severity: Low. Recall number: Z-0173-2014.
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