Product Wiki · Recalls · Health Canada — Medical Devices

AQURE SYSTEM (2016-01-29) — recall 54718

Health Canada — Medical Devices · Canada · 2016-01-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54718
Date of alert
2016-01-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Radiometer has been made aware that the AQURE system, may display the sample type as "blank", if the sample type is not specified by the user. As multiple result values for the same patient and the same parameter can be displayed side by side on the screen, there is a potential risk of misinterpretation of results, the user may confuse the blank/unspecified sample type with the content of a specified sample type field.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aqure-system-2016-01-29

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