Siemens recalls Atellica CH 930 analyzers with software V1.25.1 or older due to potential test result errors from reagent expiration and parameter shifts. Affected units may need software update to prevent inaccurate patient results.
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results
Siemens is recalling Atellica CH 930 clinical analyzers with software version 1.25.1 or older. These units could show incorrect test results because the software might reset test parameters or let reagents expire before use, risking inaccurate patient diagnoses.
The software versions V1.25.1 and older can cause test parameters to reset to default values, shifting results by the assay correlation factor. Additionally, the software may not update reagent expiration dates, leading to expired reagents being used and potentially causing incorrect patient test results.
Healthcare facilities using Atellica CH 930 analyzers with software version 1.25.1 or older are most affected. Patients receiving tests from these devices may face inaccurate results if the software issue persists.
Check for Siemens Healthcare Atellica CH 930 analyzers with software version 1.25.1 or lower. The product has a Siemens Material Number (SMN) 11067000 and UDI 00630414002163.
Review the software version on your Atellica CH 930 analyzer to confirm if it is 1.25.1 or lower.
Software versions 1.25.1 and lower may cause test parameters to reset to default values, shifting results by the assay correlation factor. They can also prevent reagent expiration dates from updating, leading to expired reagents being used.
Check for Siemens Material Number (SMN) 11067000 and software version 1.25.1 or lower on your Atellica CH 930 analyzer.
The recall does not specify a remedy, so contact Siemens Healthcare for guidance on updating the software to a newer version.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0449-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0449-2022 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.
