Radiometer recalls ABL800 FLEX blood analyzers with model 393-800/0570 that may mix up patient samples due to barcode errors, risking delayed treatment.
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment
Radiometer is recalling ABL800 FLEX blood analyzers that could mix up patient samples because of a barcode reading error. This might cause delayed medical treatment if samples are mislabeled.
The analyzer's barcode reader misreads patient ID or sample labels because the barcodes lack a check digit. This error can cause patient samples to be mixed up or lost, leading to delayed medical treatment.
Healthcare professionals using the ABL800 FLEX analyzers with model numbers 393-800/0570 or 393-801/0570 are most at risk. Patients receiving blood tests via these devices could be affected if samples are mislabeled.
Check for model numbers 393-800/0570 or 393-801/0570 on the device. The product was sold with software versions below 6.19.
Verify the software version is below 6.19 to confirm if the device is affected.
Reach out to Radiometer Medical ApS for guidance on next steps if the device is affected.
The analyzer's barcode reader misinterprets patient ID labels due to barcodes without a check digit, which could mix up samples or cause delays in treatment.
Model numbers 393-800/0570 and 393-801/0570 with software versions below 6.19.
The recall record does not mention a specific remedy or fix.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1684-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1684-2020 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.
