Health product recall

Aqure System

Last updated

Summary

Product
Aqure System
Issue
Medical devices - Device compatibility
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Aqure System

Version 2.5.2
Version 2.5.4
Version 2.6.0
Version 2.5.3
Version 2.6.1

933-599

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Radiometer Medical Aps

Akandevej 21, Bronshoj, Denmark, 2700

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73335

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