Siemens Healthcare recalls CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to potential incorrect patient results from faulty quality control checks.
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 software versions of their CentraLink Data Management System. If the software has a bug in its quality control checks, it could report incorrect patient results even when the quality control seems to pass.
The software may assign quality control results to the wrong control lot number. This can happen even when the quality control appears to be passing, leading to incorrect patient results if the issue isn't detected during quality control review.
Clinical laboratory staff using CentraLink software versions 16.0.2 and 16.0.3 are affected. Laboratories using these versions are most at risk of reporting incorrect patient results.
Check for CentraLink Data Management System software versions 16.0.2 (UDI: 00630414220635) or 16.0.3 (UDI: 00630414237268). These versions were sold with Siemens Material Numbers 11313246 and 11314337.
Identify your CentraLink software version by checking the UDI (Unique Device Identifier) on the software or documentation.
The software may assign quality control results to the wrong control lot number, leading to incorrect patient results if the issue isn't detected during quality control review.
Check for CentraLink Data Management System software versions 16.0.2 (UDI: 00630414220635) or 16.0.3 (UDI: 00630414237268).
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-2437-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2437-2020 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.
