Device product
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.
Z-0173-2014
Product summary
- Event
- Event 66132
- Status
- Terminated
- Classification
- Class III
- Quantity
- 595 kits total (5 kits with packaging error)
- Official record key
device-enforcement:Z-0173-2014
Official wording
Reason: PTH Calibrator packaged with only high calibrator.
Code information: Kit Lot: 14136A16 04 Mar 2014
Distribution pattern: Nationwide Distribution including MD, PA, and CT.
Derived failure modes
-
Unknown
PTH Calibrator packaged with only high calibrator.