Siemens Healthcare recalls ADVIA 21:10i hematology analyzers with software versions 6.10 and 6.11 due to potential sample identification mismatches with 14-character barcodes. Affected units have specific UDI numbers.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare is recalling ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11. These models may misidentify samples using 14-character barcodes, which could lead to incorrect test results.
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 mislabeled.
Healthcare facilities using Siemens ADVIA 2120i analyzers with software versions 6.10 or 6.11 are likely affected. Laboratory staff handling samples with these devices face the highest risk.
Check if your ADVIA 2120i analyzer has software versions 6.10 or 6.11. The unique device identifier (UDI) number 00630414581965 indicates affected units.
Review your device's software version to confirm if it 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 for software versions 6.10 or 6.11 and the unique device identifier (UDI) number 00630414581965.
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-1390-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1390-2021 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.
