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Recall Observatory FDA recall evidence

Device product

cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

Z-0083-2022

September 03, 2021

Class II

Product summary

Firm
Roche Molecular Systems, Inc.
Event
Event 88607
Status
Ongoing
Classification
Class II
Quantity
507 US; 6,676 ex- US
Official record key
device-enforcement:Z-0083-2022

Official wording

Reason: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

Code information: All lot numbers

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment