Siemens Healthineers recalls Immulite 2000 Syphilis Screen due to potential false negatives in syphilis testing. Affected units may miss infections; contact for remedy.
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthineers is recalling its Immulite 2000 Syphilis Screen test due to a risk of false negatives. This means the test might incorrectly show a non-reactive result when the patient actually has syphilis, potentially missing infections.
The test may incorrectly report a non-reactive result for syphilis when the patient is actually infected. This false negative could lead to undetected infections and potential health risks if untreated.
Healthcare facilities using the Immulite 2000 Syphilis Screen may be affected. Patients undergoing syphilis testing with this device could be at risk of missing infections.
Check for the product name 'Immulite 2000 Systems SYP Syphilis Screen' with lot code D387 and UDI 00630414976891. The recall applies to specific units sold by Siemens Healthineers.
Verify the lot code and UDI number on the device to confirm if it's affected.
The recall involves a potential false negative risk, meaning the test might miss infections. This is a low-risk issue as it does not cause immediate harm but requires careful testing.
Check for the lot code D387 and UDI number 00630414976891 on the Immulite 2000 Syphilis Screen device.
The recall does not specify a remedy, so contact Siemens Healthineers directly for guidance on next steps.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-2965-2026 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-2965-2026 from Siemens Healthineers. 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.
