Siemens recalls Atellica IM 1300 analyzers that may produce incorrect total T3 test results due to incompatibility with Test Definition Version 1.4. Affected units include all lots with Siemens Material Number 11066001.
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Siemens is recalling all Atellica IM 1300 analyzers that may produce incorrect total T3 test results. This could lead to inaccurate thyroid function tests if the device is used with Test Definition Version 1.4 software.
The analyzer may generate incorrect total T3 results when used with Test Definition Version 1.4 software. This incompatibility could lead to inaccurate thyroid function tests if the device is not properly updated.
Healthcare facilities using the Atellica IM 1300 analyzer for clinical testing are likely affected. Laboratories that have not updated their software to the latest version may be at risk.
Check for Siemens Material Number 11066001 on the device. All lots of the Atellica IM 1300 analyzer are affected, as per the recall notice.
Ensure the analyzer is updated to a version compatible with Test Definition Version 1.4.
The analyzer may produce incorrect total T3 results when used with Test Definition Version 1.4 software.
All lots of the Atellica IM 1300 analyzer with Siemens Material Number 11066001 are affected.
No, but you should check if your software is updated to a version compatible with Test Definition Version 1.4.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1252-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1252-2022 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.
