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
Siemens Healthcare is recalling Centaur Syphilis Assay kits that could carry over into other diagnostic tests if used right after syphilis testing on certain machines. This might lead to inaccurate test results for other conditions.
The syphilis assay kit can contaminate other tests if used right after testing on specific Siemens machines. This carryover effect causes inaccurate results for other diagnostic tests.
Healthcare labs using the Centaur Syphilis Assay kits with ADVIA Centaur XP/XPT or CP systems are affected. Labs testing for syphilis and then immediately running other assays are most at risk.
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.
Identify the lot number on the kit packaging to confirm if it's affected (all lots are impacted).
Ensure the kit is used with ADVIA Centaur XP/XPT or CP systems for in vitro diagnostics.
The recall applies to all lots of the Centaur Syphilis Assay kits. If your lab uses these kits with ADVIA Centaur XP/XPT or CP systems, you may need to adjust testing procedures to avoid carryover.
The syphilis assay can contaminate other tests if used immediately after syphilis testing on specific machines, leading to inaccurate results for other conditions.
The recall does not require discarding kits. Labs should check lot numbers and adjust testing procedures to avoid carryover effects.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1674-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1674-2021 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
