Product Wiki · Recalls · Health Canada — Medical Devices

ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS (2017-10-02) — recall 57539

Health Canada — Medical Devices · Canada · 2017-10-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57539
Date of alert
2017-10-27
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: According to the complaint, sample measurement is done using FleXQ and the registration receipt barcode is created automatically, and customer can see a patient's data directly on the analyzer using the registration receipt barcode. In this case, when the registration receipt barcode was read by the analyzer, the analyzer presented the result from a different patient. The incident could not be reproduced.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/abl800-flex-system-instrument-

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