Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Recalled by Roche Molecular Systems, Inc. Due to False Mutation Detected results for the exon 20...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Molecular Systems, Inc. directly.
Affected Products
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Quantity: 507 US; 6,676 ex- US
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report