ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur… — Class II medical device recall Z-0128-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-11-05, distributed nationwide. Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the A
| Recall number | Z-0128-2015 |
|---|---|
| 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 | 2012-10-09 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CN, EG, HK, IL, IN, JP, KR, MX, MY, PH, SA, SG, UY, VE, VN, ZA |
| Quantity | 8,263 kits |
| Reason classes | potency |
| Lot numbers | 82052A22, 82335A22, 82909A22, 85268A22, 86701B22, 88921B22, 89956B22, 90925B22, 91336B22, 95231A23, 95553A23 |
| Model numbers | 03439230 |
| Expiration dates | 2013-01-16, 2013-01-19 |
Product
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Reason for recall
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
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-0128-2015. 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.