Product Wiki · Recalls · Health Canada — Medical Devices

Alissa Interpret — recall 74986

Health Canada — Medical Devices · Canada · 2024-02-01 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 74986
Date of alert: 2024-02-01
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: General hospital and personal use
Product type: Medical devices

Reported risk: 1. The ACMG (American College of Medical Genetics and Genomics) classification scheme implemented in Alissa Interpret does not result in variant of uncertain significance (VOUS) classification when benign and pathogenic variant are contradictory. 2. The ACMG classification scheme does not result in the correct classification when the criteria strength is updated. Recall Start Date: December 21, 2023

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alissa-interpret

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Alissa Interpret — recall 74986

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