Class II — Siemens Healthcare Diagnostics, Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| 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 |
| Quantity | 22550 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fed., Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., Ukraine, United Kingdom. |
| Initiated | 2021-04-21 |
| Classified | 2021-05-24 |
| Recall number | Z-1674-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc (Z-1674-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87770/
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