BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0083-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0083-2022
    Event ID
    88607
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    September 3, 2021
    Classification Date
    October 8, 2021
    Address
    1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

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

    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 Info

    All lot numbers

    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.

    Quantity

    507 US; 6,676 ex- US