BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0696-2013 · Initiated November 19, 2012

    Recall

    Recall Number
    Z-0696-2013
    Event Number
    63617
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 19, 2012
    Posted
    January 18, 2013
    Terminated
    January 13, 2014
    Address
    9115 Hague Road, Indianapolis, IN, 46256-1025

    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

    Action

    Roche sent an Urgent Medical Device Correction letter on November 19, 2012, to all affected customers via UPS Ground (receipt required). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached form and return by fax and file this Medical Device Correction for future reference. For technical support customers were instructed to contact Diagnostics Technical Support at 1-900-428-2336. For questions regarding this recall call 317-521-3911.

    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