Radiometer recalls ABL800 FLEX analyzers with model numbers 393-800 and 393-801 due to potential pH bias from bacterial growth in calibration solutions. Users should check their device model and contact Radiometer for remediation.
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
Radiometer is recalling specific models of ABL800 FLEX analyzers because bacterial growth in calibration solutions can cause inaccurate pH readings on blood samples. This means test results might be wrong, but the risk is low if you follow proper cleaning and calibration procedures.
Bacterial growth in the calibration solution bottles can lower the pH during use, which may cause the analyzer to report inaccurate pH results on blood samples. This could lead to incorrect medical decisions if the test results are relied upon.
Users of Radiometer ABL800 FLEX analyzers with model numbers 393-800 or 393-801 are affected. Healthcare professionals using these devices for blood testing are most at risk.
Check if your ABL800 FLEX analyzer has model numbers 393-800 or 393-801. The device is intended for in vitro testing of blood samples and expired air.
Look for model numbers 393-800 or 393-801 on your ABL800 FLEX analyzer.
Reach out to Radiometer Medical ApS for further instructions on remediation.
The risk is low: bacterial growth in calibration solutions can cause inaccurate pH readings, but this does not cause immediate harm if proper cleaning and calibration procedures are followed.
No, you do not need to stop using it immediately. Radiometer recommends checking your model number and contacting them for remediation steps.
Check if your ABL800 FLEX analyzer has model numbers 393-800 or 393-801. These specific models are affected.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-2426-2024 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-2426-2024 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.
