Siemens Healthcare recalls Atelia IM 1300 analyzers for in vitro diagnostics if multiple units are connected to one solution system, risking inaccurate test results.
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 Atelia IM 1300 analyzers used for clinical testing. If more than one analyzer is connected to a single solution system, test results may be inaccurate due to improper reporting and conversion factors.
The hazard occurs when multiple immunoassay analyzers share a single solution system. This can cause reporting and conversion factors to be applied incorrectly across analyzers, leading to inaccurate test results. The issue does not involve physical harm but affects test accuracy.
Healthcare facilities using the Atelia IM 1300 analyzer for clinical testing are most likely affected. The risk is low as it only impacts test accuracy when multiple analyzers are connected to one system.
Check for the Atelia IM 1300 analyzer with UDI 00630414007960. This product is used for in vitro diagnostic testing of clinical specimens.
Ensure only one analyzer is connected to each solution system to prevent inaccurate test results.
The recall occurs because connecting more than one analyzer to a single solution system can cause reporting and conversion factors to be applied incorrectly, leading to inaccurate test results.
The Atelia IM 1300 analyzer with UDI 00630414007960 is the recalled product used for clinical specimen testing.
Ensure only one analyzer is connected to each solution system to prevent inaccurate test results. No immediate action is required beyond checking your setup.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1586-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1586-2018 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.
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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.
