Siemens Healthineers recalls Immulite 2000 Syphilis Screen systems that may report false negatives for syphilis tests, risking undetected infections. Affected units include specific lot codes and reference numbers.
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen systems that might incorrectly show nonreactive results for syphilis tests, potentially missing infections. This could lead to undiagnosed syphilis cases if the test fails to detect the disease properly.
The syphilis screen assay may incorrectly report a nonreactive result when the patient actually has syphilis. This false negative could lead to undiagnosed syphilis infections, which can cause serious health complications if untreated.
Healthcare facilities using the Immulite 2000 Syphilis Screen systems with the specified lot codes and reference numbers are affected. Patients undergoing syphilis testing with these systems may be at risk of undetected infections.
Check for lot codes D387 and reference numbers L2kSY2/10489085 or L2KSY6/10488319 on the system. The product is sold as an IVD (in vitro diagnostic) device for syphilis testing.
Verify the lot code and reference numbers on your Immulite 2000 Syphilis Screen system to confirm if it is affected.
The syphilis screen assay may contain a negative patient bias, causing low reactive patient results to be reported as nonreactive, which could miss syphilis infections.
The recall record does not specify a remedy, so check the product details to confirm if it is affected and contact Siemens Healthineers for further guidance.
The recall indicates a potential for undiagnosed syphilis infections, but the hazard does not involve physical injury or death in normal use. This is a low-risk issue.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-2966-2026 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-2966-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
