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Abl800 basic and abl8xx flex analyzers
Official notice
20 Jun 2024
Last checked
20 Jun 2024
An official Health Canada notice concerns Abl800 basic and abl8xx flex analyzers. 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 Published 2024-06-20.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75706
Official notice
2024-06-20
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
Company & contacts
Company & contacts
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Brand: Radiometer Medical Aps, Abl800 Basic And Abl8xx Flex Analyzers.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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