ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests — Class II medical device recall Z-1512-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2013-06-12, distributed nationwide. iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
| Recall number | Z-1512-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2013-05-14 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2015-03-05 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| Lot numbers | 056301, 56302, 61655301, 61950302 |
| Model numbers | 10492368 |
Product
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Reason for recall
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1512-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.