Siemens Healthcare recalls Atellica IM 1600 analyzers with software version V1.23.1 or lower. Scanning new reagent kits may reset custom settings to defaults, potentially affecting test results.
Test Definition scanning may reset custom settings to defaults. 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 Healthcare is recalling Atellica IM 1600 analyzers that may reset custom test settings when scanning new reagent kits. This could lead to inaccurate test results if settings are reset to defaults. Affected units have software version V1.23.1 or lower.
Scanning a new reagent kit with a newer TDef version than the current system settings may reset custom test parameters to default values. This could cause inaccurate diagnostic results if the settings were adjusted for specific tests.
Healthcare facilities using Siemens Atellica IM 1600 analyzers with software version V1.23.1 or lower are most at risk. This affects laboratories that perform in vitro diagnostic tests.
Check for Siemens Material Number (SMN) 11066000 and software version V1.23.1 or lower. The device is an automated immunoassay analyzer for clinical testing.
Verify the software version on your Atellica IM 1600 analyzer. If it is V1.23.1 or lower, it is affected.
Scanning a new reagent kit with a newer TDef version than the current system settings may reset custom test parameters to default values, potentially causing inaccurate test results.
Check for Siemens Material Number (SMN) 11066000 and software version V1.23.1 or lower.
The recall does not specify a remedy, so 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-0474-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0474-2021 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.
