Radiometer recalls ABL90 FLEX PLUS analyzers with software below 3.4 MR2 due to barcode misreads causing patient mixups and sample loss. Affected units may delay medical treatment.
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Radiometer is recalling ABL90 FLEX PLUS lab analyzers with software versions below 3.4 MR2 because barcode labels can be misread, potentially causing patient mix-ups or lost samples that delay medical treatment.
The barcode reader may misinterpret patient ID or accession numbers from printed labels. This could lead to incorrect patient samples being processed or samples being lost, which might delay critical medical treatments.
Lab technicians and healthcare providers using the ABL90 FLEX PLUS analyzer in settings where it's intended for laboratory use. Those handling patient samples with the affected software versions are most at risk.
Check if your ABL90 FLEX PLUS analyzer has a software version below 3.4 MR2. The product is intended for laboratory use, not point-of-care settings.
Install software version 3.4 MR2 or later to fix the barcode reading issue.
The product is safe to use with current software versions, but older versions may cause barcode misreads.
Check the software version on your ABL90 FLEX PLUS analyzer; versions below 3.4 MR2 are affected.
Misread barcodes could cause patient mix-ups or lost samples, potentially delaying medical treatment.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1761-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1761-2020 from Radiometer. 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.
