Idylla EGFR mutation test
Press Release
By:
Ref: Health Canada
Published: 06/14/2024
Health product recall
Brand(s)
Last updated
2024-06-14
Product
Idylla™ EGFR mutation test
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Filter items
Showing 1 to 1 of 1 entries
Show entries
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Idylla™ EGFR mutation test | All lots. | A0060/6 |
Previous1Next
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
Details
Original published date:
2024-06-14
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
Receive notifications for new and updated recalls and alerts by category.