Siemens Healthcare recalls Atellica IM 1600 analyzers due to potential erroneous total T3 test results from incompatible Test Definition versions. Affected units include all lots with Siemens Material Number 11066000.
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Siemens Healthcare is recalling all Atellica IM 1600 analyzers because they may produce incorrect total T3 test results when using Test Definition Version 1.4. This could lead to inaccurate medical diagnoses if the device is used without proper software updates.
The analyzer may generate erroneous total T3 results when using Test Definition Version 1.4. This happens because the software version is incompatible with certain test protocols, potentially leading to inaccurate diagnostic outcomes.
Healthcare facilities using the Atellica IM 1600 analyzer for clinical testing are affected. Patients relying on accurate T3 test results from this device could be impacted if the analyzer produces incorrect results.
Check for the Siemens Material Number 11066000 on the device. All lots of the Atellica IM 1600 analyzer are affected, as per the recall notice.
Verify the Test Definition version in the analyzer's software settings to ensure it is updated to a compatible version.
The recall affects all Atellica IM 1600 analyzers with Siemens Material Number 11066000. If your lab uses Test Definition Version 1.4, you may need to update the software to avoid incorrect T3 results.
Check the Siemens Material Number (11066000) on your Atellica IM 1600 analyzer. All lots are affected, so no specific model or date range is needed.
No, the recall does not require immediate discontinuation. Users can check the software version and update it if necessary to prevent incorrect results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1253-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1253-2022 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.
