Lower riskMedical device recall · FDA · Published April 21, 2021
Siemens Centaur Syphilis Kit Recall: Carryover Risk with Other Assays
Siemens Healthcare recalls Centaur Syphilis Assay kits due to potential carryover into other tests if used immediately after syphilis testing on specific systems. Affected kits may cause inaccurate results.
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
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc333 Coney St · East Walpole, MA 02032-1516
“Siemens Centaur Syphilis Kit Recall: Carryover Risk with Other Assays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62754-siemens-centaur-syphilis-kit-recall-carryover-risk-with-other-assays. Based on FDA recall #Z-1674-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1674-2021%22&limit=1).
The FDA announced on April 21, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling its Centaur Syphilis Assay-SYP Kits due to a potential carryover hazard affecting other assays. The agency classified the recall as Class II.
How to tell if you have it
Brand: Siemens Healthcare
Product: Centaur Syphilis Assay-SYP Kit, 200 Test
SMN: 10492493
Lots: All Lots
Units affected: 22,550
The hazard
The FDA stated that the ADVIA Centaur Syphilis assay may carry over into other commercial assays. This effect occurs only when impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (August 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026), Syphilis Test Recall (November 3, 2025), and Bayer Stellant FLEX Syringe Kit Recall (July 31, 2026).
How to tell if you have this one
Check for Centaur Syphilis Assay-SYP Kit, 200 Tests. All lots are affected. The product is used with ADVIA Centaur XP/XPT or CP systems for in vitro diagnostics.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Identify the lot number on the kit packaging to confirm if it's affected (all lots are impacted).
Verify System Compatibility
Ensure the kit is used with ADVIA Centaur XP/XPT or CP systems for in vitro diagnostics.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1674-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1674-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.