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 software updates to prevent errors.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare is recalling certain ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11. These units could cause sample identification mismatches with 14-character barcodes, potentially leading to incorrect test results.
The software versions 6.10 and 6.11 may misread 14-character barcodes used for sample identification. This could cause the analyzer to process the wrong sample, leading to incorrect test results. The risk is limited to specific software versions and does not involve physical harm.
Healthcare facilities using the ADVIA 2120i with software versions 6.10 or 6.11 are most at risk. Patients receiving lab tests on these devices may experience inaccurate results.
Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11. The product includes the Single Aspirate Autosampler (SMN 11219529) and is labeled as RoHS compliant.
Verify your device's software version by checking the device settings or documentation.
The software versions 6.10 and 6.11 may cause sample identification mismatches with 14-character barcodes, potentially leading to incorrect test results.
Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11, as these specific versions are affected.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance on 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-1404-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1404-2021 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.
