Recall Z-1513-2013 ยท CEW Radioimmunoassay, Parathyroid Hormone
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
| 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 | 3302 Kits (500 test) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY Siemens Healthcare Diagnostics, Mar 21, 2013 |