Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

Recall date

September 3, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0083-2022

FDA classification

Class II

Brand / firm

Roche Molecular Systems, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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