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Idylla™ egfr mutation test
Official notice
14 Jun 2024
Last checked
14 Jun 2024
An official Health Canada notice concerns Idylla™ egfr mutation test. 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 Published 2024-06-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75667
Official notice
2024-06-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Biocartis, Idylla™ Egfr Mutation Test.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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