FDA-Device2021-10-20Class II
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche Molecular Systems, Inc.
Hazard
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Sold states
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.
Affected count
507 US; 6,676 ex- US
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2022Don't want to check this manually?
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