medical Class II Updated 2021-10-20

Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection

Recalled Product

cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190


Hazard / Issue

False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers
View official government recall

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