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Roche Molecular Systems, Inc. Recall 88607

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

Roche Molecular Systems, Inc. Recall 88607 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0083-2022
Event ID88607
Event Descriptioncobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Product TypeDevices
DistributionWorldwide 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.
Quantity507 US; 6,676 ex- US
Recall ReasonFalse Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Device Classification20211020
Device Code InfoAll lot numbers
Center Classification Date20211008
Recall Initiation Date20210903
Recalling FirmRoche Molecular Systems, Inc.
Initial Notification Letter
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