Health product recall

Abl800 Basic And Abl8xx Flex Analyzers

Last updated

Summary

Product
Abl800 Basic And Abl8xx Flex Analyzers
Issue
Medical devices - Performance issue
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
393-800

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

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe