Siemens Healthcare recalls Atellica Data Manager software versions 1.0 and 1.1 due to potential incorrect patient results from faulty quality control checks. Affected units may need software updates or corrections.
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review
Siemens Healthcare is recalling two versions of its Atellica Data Manager software. The software could assign test results to the wrong control lot number, leading to incorrect patient results if quality control fails but appears to pass.
The software may assign test results to the wrong control lot number when quality control fails but appears to pass. This could cause incorrect patient results if the issue isn't detected during quality control reviews.
Clinical laboratory users who have Atellica Data Manager software versions 1.0 (SMN 11314237) or 1.1 (SMN 11316888) are affected. Those handling lab test results are most at risk of incorrect patient data.
Check for software versions 1.0 (SMN 11314237) or 1.1 (SMN 11316888) on your Atellica Data Manager system. The product uses unique identifiers (UDIs) starting with 00630414234946 or 006304142790.
Identify your Atellica Data Manager software version by checking the product documentation or the unique identifier (UDI) on the device.
The software may assign test results to the wrong control lot number, leading to incorrect patient results if quality control fails but appears to pass.
Check your software version and unique identifier (UDI) to see if you are affected. Contact Siemens Healthcare for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2438-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2438-2020 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.
