BEUDAMED
    FDA Enforcement Class II Terminated

    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use

    Recall: Z-1830-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1830-2016
    Event ID
    73703
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    March 15, 2016
    Classification Date
    May 26, 2016
    Termination Date
    December 11, 2017
    Address
    1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use

    Reason

    An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).

    Code Info

    EGFR v2: 07248563190 cfDNA: 07247737190

    Distribution

    Hungary

    Quantity

    8 kits