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 ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11. These versions 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 misidentify samples when using 14-character barcodes. This could lead to incorrect test results if the device mixes up samples during analysis.
Users of the ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11 are affected. Laboratory staff and healthcare providers using these devices are most at risk of incorrect test results.
Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11. The product is identified by the model number SMN 11314044 and was sold as an OUS (out-of-scope) automated hematology analyzer.
Verify your device's software version by checking the device settings or documentation.
Software versions 6.10 and 6.11.
This issue could cause sample identification mismatches with 14-character barcodes, potentially leading to incorrect test results.
The recall does not specify a remedy, so no immediate action is required beyond checking your software version.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1402-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1402-2021 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.
