Siemens Healthcare recalls Analyzer and Atellica IM 1600 systems for in vitro diagnostics due to potential inaccurate test results when multiple analyzers share a solution system. Affected units have UDI 00630414002026.
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Siemens Healthcare is recalling its Analyzer and Atellica IM 1600 systems for in vitro diagnostic testing. The recall happens because connecting more than one analyzer to a single solution system can cause inaccurate test results. This matters because incorrect results could lead to wrong medical diagnoses.
When multiple immunoassay analyzers are connected to the same solution system, the reporting and conversion factors may not apply correctly to all analyzers. This can cause some tests to show inaccurate results, potentially leading to wrong medical decisions.
Healthcare facilities using these analyzers for clinical testing are most likely affected. Patients receiving tests from these systems could be at risk of inaccurate results.
Check for the UDI code 00630414002026 on the product label. These analyzers are used for clinical specimen testing in healthcare settings.
Look for the UDI code 00630414002026 on the analyzer or Atellica IM 1600 system.
The recall is due to potential inaccurate test results when multiple analyzers share a single solution system, which could lead to wrong medical diagnoses.
Check for the UDI code 00630414002026 on the product label. This specific code identifies the affected units.
The recall does not require immediate action. Check the product label for the UDI code to confirm if your unit is affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1588-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1588-2018 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.
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.
