Radiometer recalls ABL800 blood analyzers with FLEXQ module that may display incorrect patient results due to barcode misinterpretation. Affected units have specific serial numbers.
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
Radiometer is recalling ABL800 blood analyzers with FLEXQ modules because they can show results from the wrong patient when scanning registration receipts. This could lead to incorrect medical decisions if the analyzer displays the wrong patient's data.
The analyzer misreads the barcode on registration receipts, causing it to display results from a different patient. This could lead to incorrect medical decisions if the wrong patient's data is used for treatment.
Healthcare facilities using the ABL800 analyzer with FLEXQ module for blood testing are most at risk. Patients receiving results from the wrong patient could be affected if the error occurs during testing.
Check if your ABL800 analyzer has the FLEXQ module. The device is used for blood and expired air testing and has specific serial numbers.
Identify the serial number on your ABL800 analyzer with FLEXQ module to confirm if it's affected.
The analyzer misreads the barcode on registration receipts, causing it to display results from a different patient.
Check if your ABL800 analyzer has the FLEXQ module and the specific serial numbers mentioned in the recall.
The recall does not specify a remedy, so contact Radiometer America Inc for further instructions.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-0231-2018 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-0231-2018 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.