Reported Oct 20, 2021 · Ongoing
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- cobas EGFR Mutation Test v2-Somatic gene mutation
- detection system Catalog Number07248563190
- Lot codes and dates
- All lot numbers
- Amount recalled
- 507 US; 6,676 ex- US
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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