Recall Z-1514-2013 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
| Date | Jun 6, 2013 (initiated May 14, 2013) |
| Status | Terminated |
| Reason | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability |
| Root cause | No Marketing Application |
| Action | Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support. |
| Quantity | 99 (2 pk) |
| Distribution | Nationwide Distribution. |
| 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 |