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Health Canada Medical devices

Aqure System

Issued March 16, 2023
Issue
Radiometer has become aware that there is a problem relating to the Aqure System (stand alone software system) used in combination with the third party device Lumiradx that may result in patient mix-up. Currently there are no customers in Canada using Aqure in combination with Lumiradx. The recall in Canada is initiated to prevent the issue to occur in potential future installations. Recall start date: March 3, 2023
Hazard description
Device compatibility
Product
Product name
Aqure System
Reference
ID
RA-73335