Health product recall

COBAS EGFR MUTATION TEST V2

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: 2021-12-01
Alert / recall type
Health product recall
Category
Health product » Medical device
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