BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.

    Recall: Z-1062-04 · Initiated June 18, 2004

    Recall

    Recall Number
    Z-1062-04
    Event Number
    29329
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    DIP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2004
    Posted
    July 20, 2004
    Terminated
    October 6, 2004
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.

    Reason

    May report falsely decreased patient results.

    Action

    Consignees were maile a recall letter dated 6/17/04 on 6/18/04 instructing them to cease using this lot and to advise all attending physicians of the problem.

    Distribution

    Nationwide, Canada, Germany and Spain.