Siemens Healthcare recalls ADVIA 2120i hematology analyzers with specific software versions due to potential sample identification mismatches with 14-character barcodes. Affected units may require correction to prevent misidentification of blood samples.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare is recalling ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11. This recall is due to a potential mismatch in sample identification using 14-character barcodes, which could lead to incorrect blood test results.
The software versions 6.10 and 6.11 may cause the device to misidentify blood samples using 14-character barcodes. This could lead to incorrect test results if samples are not properly matched to patient identifiers.
Healthcare facilities using the ADVIA 2120i hematology analyzers with software versions 6.10 or 6.11 are most at risk. Patients receiving blood tests from these devices may be affected if misidentification occurs.
Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11. The unique device identifier (UDI) 00630414019789 is associated with this recall.
Verify your device's software version by checking the device settings or documentation.
Reach out to Siemens Healthcare for guidance on correcting the software issue.
Software versions 6.10 and 6.11 are affected.
This could lead to incorrect blood test results if samples are misidentified using 14-character barcodes.
The recall does not specify a fix; 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-1394-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1394-2021 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.
