BEUDAMED
    FDA Recall Terminated

    GEM Premier 4000 Laboratory Analyzer

    Recall: Z-0778-2007 · Initiated March 27, 2007

    Recall

    Recall Number
    Z-0778-2007
    Event Number
    37719
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2007
    Posted
    May 3, 2007
    Terminated
    May 23, 2012
    Address
    113 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    GEM Premier 4000 Laboratory Analyzer

    Reason

    Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result

    Action

    Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07

    Distribution

    Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden

    Quantity

    210