ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B… — Class III medical device recall Z-2410-2012
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2012-09-26, distributed nationwide. ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lot
| Recall number | Z-2410-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2012-08-07 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2014-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, EG, GB, HK, HR, IL, IN, JP, KR, MX, NZ, PE, PK, SG, TH, TW, VN, ZA |
| Quantity | 15,445 kits |
| Reason classes | potency |
| Lot numbers | 78813A30, 79354A30, 79982A30, 80802A30, 81013A30, 81892B30, 82021B30, 82767B30, 82815B30, 83453C30, 83741D30, 84186A40, 85447D30, 85598A40, 85708A40, 86098A40, 87319A40, 87979B40, 88809B40, 89351C40, 91750C40 |
| Model numbers | 00649625, 00650577, 00652707, 00654130, 00654254, 78319A29, 78487A29, 79024A29, 79403A29, 79714A30, 79770B29, 79981B29, 82370A30, 82935B29, 84274A30, 85512E30, 85735C29 |
| Expiration dates | 2012-12-02, 2013-04-09 |
Product
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for recall
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
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-2410-2012. 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.