Siemens Healthcare recalls ADVIA 2120i hematology analyzers with specific software versions due to potential sample identification mismatches with 14-character barcodes. Affected units may need 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. The issue could cause sample identification mismatches with 14-character barcodes, potentially leading to incorrect test results.
The software versions 6.10 and 6.11 may cause the device to misread 14-character barcodes used for sample identification. This could lead to incorrect test results if the barcode is not properly matched to the sample.
Healthcare facilities using Siemens ADVIA 2120i analyzers with software versions 6.10 or 6.11 are most at risk. Patients receiving lab tests on these devices may be affected if the software error occurs.
Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11. The device includes a Single Aspirate Autosampler (SMN 10488923).
Verify your device's software version is 6.10 or 6.11 to determine if it is affected.
The recall may cause incorrect test results if the software error occurs. Affected devices should be updated to prevent mismatches.
The official recall does not specify a fix. Affected users should check for software updates or contact Siemens Healthcare for guidance.
No, the recall does not require immediate discontinuation. Affected devices can continue to be used after updating the software.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1400-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1400-2021 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.
