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Official recall record

Abl800 Basic And Abl8xx Flex Analyzers

Health Canada — Medical Devices · 2024-06-20 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-06-20
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Radiometer has become aware of an issue with the Abl800 series analyzers. An internal study has concluded that there is a remote probability of reporting biased out-of-specification pH results on blood samples. This may occur if the calibration solution's pH value decreases during the in-use period due to bacterial growth in the calibration solution bottles Cal1 and/or Cal2. Recall start date: June 4, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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