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Abl800 flex system
Official notice
24 May 2022
Last checked
24 May 2022
An official Health Canada notice concerns Abl800 flex system. Radiometer has become aware of a potential issue with abl800 basic and abl8xx flex analyzers with software versions below v6.19 mr2 and configured to report cna+. We have received sporadic incidents of positive and negative biases for cna+, that potentially could lead to serious health consequences. The issue may show when using specific micro measuring modes. The issue is caused by a combination of software and analyzer specific hardware related to sample transport. Recall start date: May 10, 2022 Published 2022-05-24.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64188
Official notice
2022-05-24
The hazard
The hazard
Radiometer has become aware of a potential issue with abl800 basic and abl8xx flex analyzers with software versions below v6.19 mr2 and configured to report cna+. We have received sporadic incidents of positive and negative biases for cna+, that potentially could lead to serious health consequences. The issue may show when using specific micro measuring modes. The issue is caused by a combination of software and analyzer specific hardware related to sample transport. Recall start date: May 10, 2022
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.
Recall Numbers
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Affected products
Product 1
Risk / hazard
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.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Radiometer Medical Aps, Abl800 Flex System.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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