ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determinatio
FDA device recall Z-1512-2013 · posted 2013-06-06 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- 309 (100 test) kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-14
- Date posted
- 2013-06-06
- Date terminated
- 2015-03-05
- Location
- East Walpole, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981) | Siemens Healthcare Diagnostics | 2013-03-21 |