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FDASeptember 3, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

roche molecular systemsrocheroche molecular

UPCs

07248563190

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 — Recall Details · AllClear