Siemens Healthcare recalls Atellica IM 1300 analyzers with specific software versions due to scanning errors with new reagent lots. Affected units have Siemens Material Number 11066001 or UDI 00630414007960.
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
Siemens Healthcare is recalling Atellica IM 1300 analyzers with software versions V1.19.0 and V1.19.2. These versions can cause scanning errors when using new reagent lots, potentially leading to inaccurate test results.
The software versions V1.19.0 and V1.19.2 have issues scanning new reagent lot test definitions. This can cause inaccurate test results if the analyzer is used with certain reagents, but does not pose a direct safety hazard to users.
Lab technicians and healthcare facilities using Siemens Atellica IM 1300 analyzers with the specified software versions. Users most at risk are those handling reagent lots that may be affected by the scanning error.
Check for Siemens Material Number (SMN) 11066001 or Unique Device Identifier (UDI) 00630414007960 on the analyzer's label. The affected software versions are V1.19.0 and V1.19.2.
Verify the software version on your Atellica IM 1300 analyzer. If it is V1.19.0 or V1.19.2, it is affected.
Software versions V1.19.0 and V1.19.2 on the Atellica IM 1300 analyzer.
Check for Siemens Material Number (SMN) 11066001 or Unique Device Identifier (UDI) 00630414007960 on the analyzer's label.
No action is needed if your software version is not V1.19.0 or V1.19.2.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0204-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0204-2020 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.
