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Health Canada Medical devices

Abl800 Basic And Abl8xx Flex Analyzers

Issued June 20, 2024
Issue
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
Hazard description
Performance
Product
Product name
Abl800 Basic And Abl8xx Flex Analyzers
Reference
ID
RA-75706