Siemens recalls ADVIA 2120 hematology analyzers with software versions 6.10 and 6.11 due to potential sample identification mismatches with 14-character barcodes.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens is recalling ADVIA 2120 hematology analyzers with specific software versions because they might misidentify samples using 14-character barcodes. This could lead to incorrect test results if samples are not properly matched.
The software versions 6.10 and 6.11 may cause sample identification mismatches when using 14-character barcodes. This could result in incorrect test results if samples are not properly matched, but does not cause physical harm.
Healthcare facilities using Siemens ADVIA 2120 analyzers with software versions 6.10 or 6.11 are affected. Labs handling blood tests are most at risk due to potential misidentification of samples.
Check if your ADVIA 2120 hematology analyzer has software versions 6.10 or 6.11. The unique device identifier (UDI) is 00630414501208.
Verify your ADVIA 2120 software version is 6.10 or 6.11.
The software versions 6.10 and 6.11 may cause sample identification mismatches with 14-character barcodes, potentially leading to incorrect test results.
Check if your ADVIA 2120 has software versions 6.10 or 6.11, and the unique device identifier (UDI) is 00630414501208.
The recall does not specify a remedy, so contact Siemens Healthcare 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-1386-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1386-2021 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.
