Siemens ADVIA Centaur¿ Syphilis — Class II medical device recall Z-2228-2012
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2012-08-29, distributed nationwide. Syphilis Assay Interference with HBsAg Assay
| Recall number | Z-2228-2012 |
|---|---|
| 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 | 2012-07-17 |
| Classified | 2012-08-20 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2013-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CN, DK, HK, MY, NZ, VN |
| Quantity | 2,050 kits |
| Reason classes | potency |
| Lot numbers | 77749002, 80615003, 82640003, 84120003, 85456003, 86036003, 87129003, 88440003, 90054004, 90422004 |
Product
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis
Reason for recall
Syphilis Assay Interference with HBsAg Assay
Machine access
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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.