FDA Recall
Terminated
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.
Recall: Z-0173-2014
·
Initiated August 16, 2013
Recall
- Recall Number
- Z-0173-2014
- Event Number
- 66132
- Firm
- Siemens Healthcare Diagnostics, Inc
- FEI Number
- 1219913
- Product Code
- CEW
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- August 16, 2013
- Posted
- November 6, 2013
- Terminated
- February 13, 2014
- Address
- 333 Coney St, East Walpole, MA, 02032-1516
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
PTH Calibrator packaged with only high calibrator.
Action
Packaging error was brought to Siemens' attention through escalations received from (3) customers in the United States. Internal Investigation confirmed the issue was limited to the five (5) kits distributed to these customers. As the customers were aware of the issue and non affected product was provided to the customers to use during Siemens' investigation, no further communication was warranted.
Distribution
Nationwide Distribution including MD, PA, and CT.
Quantity
595 kits total (5 kits with packaging error)