BEUDAMED
    FDA Recall Terminated

    GEM PREMIER 3000

    Recall: Z-0378-06 · Initiated December 16, 2005

    Recall

    Recall Number
    Z-0378-06
    Event Number
    34249
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2005
    Posted
    January 11, 2006
    Terminated
    May 21, 2007
    Address
    113 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    GEM PREMIER 3000

    Reason

    Software error may report higher results for glucose and lactate

    Action

    Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 2006.

    Distribution

    Nationwide Foreign: Canada

    Quantity

    2021 units