Centaur Syphilis Assay-SYP Kit — Class II medical device recall Z-1674-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc, reported 2021-06-02, distributed nationwide. Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effec
| Recall number | Z-1674-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2021-04-21 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, CH, CZ, DE, EG, ES, FI, FR, GB, GR, HR, IT, LV, NL, NO, PL, PT, QA, RS, SE, SK, TR, UA |
| Quantity | 22,550 units |
| Reason classes | potency |
Product
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
Reason for recall
Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems
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-1674-2021. 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.