BEUDAMED
    FDA Enforcement Class II Terminated

    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

    Recall: Z-0042-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0042-2020
    Event ID
    83467
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    July 23, 2019
    Classification Date
    October 4, 2019
    Termination Date
    June 8, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

    Reason

    Inaccurately Low Sample Results

    Code Info

    All Lots

    Distribution

    AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY

    Quantity

    27676 units