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Health Canada Medical devices

Alissa Interpret

Issued February 1, 2024
Issue
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
Hazard description
Performance
Product
Product name
Alissa Interpret
Reference
ID
RA-74986