cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Reported: October 20, 2021 Initiated: September 3, 2021 #Z-0083-2022
Product Description
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Reason for Recall
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 507 US; 6,676 ex- US
- Distribution
- 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, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190. Recalled by Roche Molecular Systems, Inc.. Units affected: 507 US; 6,676 ex- US.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0083-2022.
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