Siemens Healthcare recalls Atellica IM 1600 analyzers with specific software versions due to scanning errors with new reagent lots. Affected units have Siemens Material Number 11066000 or UDI 00630414002026. No immediate action needed but check software version.
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 1600 Analyzers with software versions V1.19.0 and V1.19.2 because they may scan new reagent lots incorrectly. This could lead to inaccurate test results if the software fails to handle reagent lot definitions properly.
The software versions V1.19.0 and V1.19.2 may not correctly process new reagent lot definitions, leading to inaccurate test results. This could affect the reliability of diagnostic tests if the analyzer fails to scan reagent lots properly.
Laboratory users with Atellica IM 1600 Analyzers running software versions V1.19.0 or V1.19.2 are most at risk. These units have Siemens Material Number 11066000 or UDI 00630414002026.
Check for Siemens Material Number 11066000 or Unique Device Identifier (UDI) 00630414002026 on the analyzer. The software version should be V1.19.0 or V1.19.2.
Verify the software version on your Atellica IM 1600 Analyzer. If it is V1.19.0 or V1.19.2, it is affected.
No immediate action is required. The recall involves software versions that may cause scanning errors with new reagent lots, but no stop-use instruction is provided.
Check the software version. If it is V1.19.0 or V1.19.2, contact Siemens Healthcare for guidance on potential fixes or updates.
Look for Siemens Material Number 11066000 or Unique Device Identifier 00630414002026. The software version should be 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-0205-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0205-2020 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.
