Recall Z-0173-2014 ยท CEW Radioimmunoassay, Parathyroid Hormone
Siemens Healthcare Diagnostics, Inc
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.
| Date | Nov 6, 2013 (initiated Aug 16, 2013) |
| Status | Terminated |
| Reason | PTH Calibrator packaged with only high calibrator. |
| Root cause | Packaging |
| 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. |
| Quantity | 595 kits total (5 kits with packaging error) |
| Distribution | Nationwide Distribution including MD, PA, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020217 | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY Bayer Diagnostics Corp., Mar 15, 2002 |