BEUDAMED
    FDA Recall Terminated

    GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use

    Recall: Z-0846-03 · Initiated March 7, 2003

    Recall

    Recall Number
    Z-0846-03
    Event Number
    25810
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2003
    Posted
    May 20, 2003
    Terminated
    May 23, 2012
    Address
    113 Hartwell Avenue, Lexington, MA, 02173

    Description

    GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use

    Reason

    Incorrect bar code applied to cartridges could result in inaccurate pO2 value

    Action

    IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.

    Distribution

    CA, FL, NY, PA, TN,

    Quantity

    2