Idylla™ EGFR mutation test
Brand(s)
Last updated
Summary
Product
Idylla™ EGFR mutation test
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 |
|---|---|---|
Idylla™ EGFR mutation test |
All lots. |
A0060/6 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Biocartis NV
Generaal De Wittelaan, Mechelen, Belgium, 2800
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75667
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