Recall Z-0173-2014
Siemens Healthcare Diagnostics, Inc · initiated August 16, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Kit Lot: 14136A16 04 Mar 2014
Reason for recall
PTH Calibrator packaged with only high calibrator.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-0173-2014
- Initiated
- August 16, 2013
- Posted by FDA
- November 6, 2013
- Terminated
- February 13, 2014
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Quantity
- 595 kits total (5 kits with packaging error)
- Distribution
- Nationwide Distribution including MD, PA, and CT.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA