COBAS EGFR MUTATION TEST V2
Brand(s)
Last updated
Summary
Product
COBAS EGFR MUTATION TEST V2
Issue
Medical devices - Inaccurate test or measurement results
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| COBAS EGFR MUTATION TEST V2 | All lots. | Not applicable. |
Issue
|
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 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
|
ROCHE DIAGNOSTICS GMBH, SANDHOFERSTRASSE 116 MANNHEIM, GERMANY 68305 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63663
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