Siemens Healthcare recalls Atellica CH 930 Analyzers with software version v1.21.0 SP1 or lower due to potential test result errors when editing assay definitions without saving. Affected units have serial numbers listed in the recall notice.
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
Siemens Healthcare is recalling Atellica CH 930 Analyzers with software version v1.21.0 SP1 or lower. Editing assay test definitions without saving changes can cause test results to show zero for quantitative assays or negative for qualitative assays. This could lead to inaccurate medical testing.
If someone edits an assay test definition screen without saving changes and switches to another assay definition screen, the system may corrupt the settings. This can cause the analyzer to generate zero results for quantitative tests or negative results for qualitative tests if the reagent pack isn't properly calibrated.
Users of the Atellica CH 930 Analyzer with software version v1.21.0 SP1 or lower, particularly those in medical labs that perform diagnostic testing. The risk is low for most users as the issue only affects specific software configurations.
Check if your Atellica CH 930 Analyzer has software version v1.21.0 SP1 or lower. The recall includes specific serial numbers listed in the official notice. Siemens Material Number 11067000 is also associated with these units.
Verify your analyzer's software version by checking the device settings or documentation. If it is v1.21.0 SP1 or lower, it is affected.
The recall is due to a software issue where editing assay test definitions without saving changes can corrupt settings, leading to incorrect test results.
Check if your Atellica CH 930 Analyzer has software version v1.21.0 SP1 or lower. The recall includes specific serial numbers listed in the official notice.
Check your software version. If it is v1.21.0 SP1 or lower, contact Siemens Healthcare for guidance on potential fixes or updates.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1797-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1797-2020 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.
