Siemens Healthcare recalls ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11 due to potential sample identification mismatches with 14-character barcodes. Affected units may require software updates to prevent errors.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare is recalling ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11 because they may cause sample identification mismatches with 14-character barcodes. This could lead to incorrect lab results if samples are mislabeled.
The software versions 6.10 and 6.11 may cause sample identification mismatches with 14-character barcodes. This could result in incorrect lab results if samples are mislabeled, but does not cause physical harm to users.
Lab technicians and healthcare facilities using Siemens ADVIA 2120i analyzers with software versions 6.10 or 6.11 are most at risk. The recall affects medical devices used in clinical laboratories.
Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11. The device is sold by Siemens Healthcare and used in clinical laboratories.
Verify your device's software version by checking the device settings or documentation.
No, the recall does not require immediate discontinuation. You can continue using the device but should check the software version.
Software versions 6.10 and 6.11 are affected.
The official recall does not provide a fix. You may need to contact Siemens Healthcare for software updates or corrections.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1405-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1405-2021 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.
