Official recall record
Alissa Interpret
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-01
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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