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 mislabeled 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 when using 14-character barcodes, which could lead to mislabeled samples.
The software versions 6.10 and 6.11 may cause the analyzer to misread 14-character barcodes used for sample identification. This mismatch could result in incorrect sample labeling, potentially leading to misdiagnosis or incorrect treatment.
Healthcare facilities using the ADVIA 2120i hematology analyzer with software versions 6.10 or 6.11 are most at risk. Patients could be affected if samples are mislabeled due to the software issue.
Check if your ADVIA 2120i analyzer has software versions 6.10 or 6.11. The unique device identifier (UDI) is 00630414237879 for affected units.
Verify your analyzer's software version by checking the device settings or documentation. If it is 6.10 or 6.11, it is affected.
Software versions 6.10 and 6.11 may cause sample identification mismatches with 14-character barcodes, potentially leading to mislabeled samples.
Check if your ADVIA 2120i analyzer has software versions 6.10 or 6.11. The unique device identifier (UDI) 00630414237879 identifies affected units.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance on potential 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-1392-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1392-2021 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.
