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FDAJanuary 13, 2015device

cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

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

The hazard

False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.

What to do

FDA enforcement status: Terminated

Brands named

roche molecular systemsrocheroche molecular

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 epidermal growth factor receptor (EGFR) gene DNA assay — Recall Details · AllClear