BEUDAMED
    FDA Enforcement Class III Terminated

    Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

    Recall: Z-0696-2013 · Reported January 30, 2013

    Enforcement

    Recall Number
    Z-0696-2013
    Event ID
    63617
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 30, 2013
    Initiation Date
    November 19, 2012
    Classification Date
    January 18, 2013
    Termination Date
    January 13, 2014
    Address
    9115 Hague Road, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

    Reason

    A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access

    Code Info

    Part Numbers: 28065047001 and 03245233001

    Distribution

    Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.

    Quantity

    845 Units