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Cobas egfr mutation test v2
Official notice
26 Nov 2021
Last checked
26 Nov 2021
An official Health Canada notice concerns Cobas egfr mutation test v2. Roche received few complaints from customers reporting the generation of false mutation detected results for the Exon 20 insertion (EX20INS) mutation when using the Cobas EGFR mutation test V2. Recall start date: 2021-09-15 Published 2021-11-26.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63663
Official notice
2021-11-26
The hazard
The hazard
Roche received few complaints from customers reporting the generation of false mutation detected results for the Exon 20 insertion (EX20INS) mutation when using the Cobas EGFR mutation test V2. Recall start date: 2021-09-15
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: Roche Diagnostics, Cobas Egfr Mutation Test V2.
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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