Siemens Healthcare recalls Atel:lica CH 930 analyzers with software V1.20.0 and lower due to potential calibration errors causing QC results to be 5x higher than expected. Affected units have specific serial numbers and software versions.
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Siemens Healthcare is recalling Atellica CH 930 analyzers that may have calibration errors. This could cause quality control tests to show results five times higher than they should, potentially leading to inaccurate medical diagnoses.
The analyzer may produce quality control results five times higher than expected after calibration. This could lead to incorrect medical diagnoses if the elevated results are not properly interpreted.
Healthcare facilities using the Atellica CH 930 analyzer with software version 1.20.0 or lower are most at risk. Patients receiving tests on these devices may experience inaccurate results.
Check for the serial number SMN 11067000 and software version 1.20.0 or lower on the device. The unique device identifier (UDI) 00630414002163 is also associated with this recall.
Verify the software version on your Atellica CH 930 analyzer. If it is 1.20.0 or lower, it is affected.
The recall is due to potential calibration errors that may cause quality control results to be five times higher than expected after calibration.
Check for the serial number SMN 11067000 and software version 1.20.0 or lower. The unique device identifier (UDI) 00630414002163 is also associated with this recall.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0581-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0581-2020 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.
