Radiometer recalls ABL80-FLEX-393-839 box labels due to barcode misreads causing patient mix-ups or delayed treatment. Affected units sold with specific labels and serial numbers.
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
Radiometer is recalling a specific box label for their ABL80-FLEX analyzers because barcodes can misread patient IDs or accession numbers, risking patient mix-ups or delayed treatment. This is a safety issue for labs using these devices.
The barcode on the label may misinterpret patient ID or accession numbers, leading to incorrect patient identification or delayed medical treatment. This happens when the label lacks a check digit for patient identification.
Lab technicians and healthcare workers using Radiometer ABL80-FLEX analyzers with the recalled box label are most at risk. Patients receiving care through these systems could be affected if the label is misread.
Check if your ABL80-FLEX analyzer has the box label with serial number 05700693938394. The label is part of the product used in laboratory settings near patients or at point-of-care.
Look for the serial number 05700693938394 on the box label of your ABL80-FLEX analyzer.
The label's barcode may misread patient IDs or accession numbers, causing patient mix-ups or delayed treatment.
Check if your ABL80-FLEX analyzer has the specific serial number 05700693938394. If so, stop using it until you can verify the label is correct.
The recall record does not mention a fix or remedy for this issue.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-2467-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-2467-2020 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.
