Product Wiki · Recalls · Health Canada — Medical Devices

Idylla™ EGFR mutation test — recall 75667

Health Canada — Medical Devices · Canada · 2024-06-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75667
Date of alert
2024-06-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Haematology
Product type
Medical devices
Reported risk: Biocartis has identified the potential for false positive results to be generated for the S768I target when using the Idylla™ EGFR mutation test, when tests are conducted with low sample input. Recall start date: May 27, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/idyllatm-egfr-mutation-test

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