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 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 because they may cause sample identification mismatches with 14-character barcodes. This could lead to incorrect test results if samples are mislabeled.
The software versions 6.10 and 6.11 may misread 14-character barcodes on sample labels, causing the analyzer to mix up sample IDs. This could result in incorrect test results if samples are mislabeled.
Healthcare facilities using the ADVIA 2120i with software versions 6.10 or 6.11 are likely affected. Lab technicians and medical staff handling samples are at risk of incorrect test results.
Check for the model name 'ADVIA 2120i Refurb Dual Aspirate' and software versions 6.10 or 6.11. The unique device identifier (UDI) starts with 00630414237886.
Verify the software version on your ADVIA 2120i by checking the device settings or documentation.
Software versions 6.10 and 6.11.
Check for the model name 'ADVIA 2120i Refurb Dual Aspirate' and software versions 6.10 or 6.11. The unique device identifier (UDI) starts with 00630414237886.
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-1393-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1393-2021 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.
