BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0083-2022 · Initiated September 3, 2021

    Recall

    Recall Number
    Z-0083-2022
    Event Number
    88607
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OWD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 3, 2021
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    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

    Action

    Roche issued Urgent Medical Device Correction letter on 9/3/21 via UPS Ground. Letter states reason for recall, health risk and action to take: Follow the cobas DNA Sample Preparation Kit (catalog number 05985536190) IFU for sample input with regard to the number of FFPET sections and DNA concentration. Follow the cobas cfDNA Sample Preparation Kit (catalog number 07247737190) IFU for plasma samples. " If an Ex20Ins Mutation Detected result is generated with the cobas EGFR Mutation Test v2, you must confirm the result with another method (e.g., sequencing or other PCR-based tests). " Consider reviewing results generated since May 2021. Amivantamab was approved by the U.S. Food and Drug Administration (FDA) for NSCLC patients with EGFR Ex20Ins on May 21, 2021. Test result reports with Ex20Ins Mutation Detected may be considered for confirmatory testing using sequencing or other PCR-based tests, upon the discretion of a CAP/CLIA laboratory director. " Consult with your facility physician and/or pathologist to determine any clinical implications specific to your patients. " Complete all sections of the enclosed faxback form (TP-01381) and fax it to 1-855-208-4038 or email it to [email protected]. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-1247 if you have questions about the information contained in this UMDC

    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