BEUDAMED
    FDA Recall Terminated

    Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030

    Recall: Z-1109-2008 · Initiated October 12, 2007

    Recall

    Recall Number
    Z-1109-2008
    Event Number
    46387
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    CGS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 12, 2007
    Posted
    March 19, 2008
    Terminated
    March 28, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030

    Reason

    Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.

    Action

    On October 12, 2007, A Product Recall letter was provided to all Clinical Chemistry Creatine Kinase Reagent customers that have received lot number 52044HW00 . Customer reply form were included in all US customers letter. The letter instructed customers to discontinue use of the kits and destroy them following their laboratory procedure, and document the number of kits discarded. Abbott will provide reimbursement for destroyed kits.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, Chili, Uruguay, Germany, Hong Kong, and New Zealand.

    Quantity

    334 Distributed Worldwide; 164 Domestically