Alissa Interpret
Brand(s)
Last updated
Summary
Product
Alissa Interpret
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Alissa Interpret |
v5.3.7 |
K5849AA |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Agilent Technologies Belgium
Technologielaan 3, Leuven, Belgium,
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74986
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