Abl800 Basic And Abl8xx Flex Analyzers
Brand(s)
Last updated
Summary
Product
Abl800 Basic And Abl8xx Flex Analyzers
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Abl800 Basic And Abl8xx Flex Analyzers |
All lots. |
393-801 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Radiometer Medical Aps |
| Akandevej 21, Bronshoj, Denmark, 2700 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75706
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