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Aqure system

Official notice

16 Mar 2023

Last checked

16 Mar 2023

Medium riskHealth Canada

An official Health Canada notice concerns Aqure system. 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 Published 2023-03-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73335

Official notice

2023-03-16

The hazard

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

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

73335

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Affected products

Product 1

Affected products - Aqure System, Lot or serial number - Version 2.5.2 Version 2.5.4 Version 2.6.0 Version 2.5.3 Version 2.6.1, Model or catalog number - 933-599

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Radiometer Medical Aps, Aqure System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73335

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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