Siemens recalls Atellica IM 1300 analyzers with software version V1.23.1 or lower that may reset custom settings causing false test results. Affected units have Siemens Material Number 11066001.
Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Siemens is recalling Atellica IM 1300 analyzers with software version V1.23.1 or lower. These devices may reset custom test settings when scanning new reagent kits, leading to inaccurate test results. This could affect medical testing accuracy for clinical specimens.
When a new reagent kit is scanned, the system may reset custom settings to default values. This can cause test results to be falsely low or high, potentially affecting medical diagnoses. The issue occurs only when the TDef version of the reagent kit is newer than the current system version.
Healthcare facilities using Siemens Atellica IM 1300 analyzers with software version V1.23.1 or lower are likely affected. Medical staff performing in vitro diagnostics on clinical specimens are most at risk of inaccurate test results.
Check for Siemens Material Number 11066001 and software version V1.23.1 or lower. The device is an automated immunoassay analyzer for clinical specimen testing.
Verify the software version is V1.23.1 or lower by checking the device's settings menu.
The recall is due to test definition scanning resetting custom settings to defaults when scanning newer reagent kits, which can cause false test results.
It may cause test results to be falsely low or high, potentially affecting medical diagnoses if the device is used for clinical specimen testing.
Check the software version; if it is V1.23.1 or lower, contact Siemens Healthcare for guidance on potential fixes.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0473-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0473-2021 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.
