Radiometer recalls ABL90 FLEX Analyzers with software versions below 3.4MR2 due to potential patient mixups and sample loss. Affected units may require software update to prevent delayed 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 Analyzers with software versions older than 3.4MR2 because the barcode reader might misread patient labels, risking patient mixups or lost samples. This could delay critical medical treatment.
The device's barcode reader may misinterpret patient ID labels, causing mixups or lost samples. This could lead to delayed medical treatment if the wrong patient's sample is processed or samples are not properly tracked.
Lab technicians and healthcare providers using the ABL90 FLEX Analyzer in clinical settings are most at risk. Patients receiving tests via this device could be affected if the software issue occurs.
Check for model number 393-090 and software versions below 3.4MR2. The device is intended for use in labs or point-of-care settings.
Install software version 3.4MR2 or later to fix the barcode reading issue.
The barcode reader may misinterpret patient ID labels, causing mixups or lost samples, which could delay medical treatment.
Check for model number 393-090 and software versions below 3.4MR2. The device is intended for use in labs or point-of-care settings.
Update the software to version 3.4MR2 or later to prevent patient mixups and sample loss.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1760-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1760-2020 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.
