Product Wiki · Recalls · Health Canada — Medical Devices

AQURE SYSTEM (2019-07-15) — recall 60004

Health Canada — Medical Devices · Canada · 2019-08-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60004
Date of alert
2019-08-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: It was reported that during installation and validation of a third party device (TEG manager) connected to AQURE, wrong patient identification data was sent from AQURE. The data was not displayed on the device as it was rejected by the device. Thus, no patient mix-up occurred in the present case, however it could have happened.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aqure-system-2019-07-15

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