BEUDAMED
    FDA Recall Terminated

    Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0288-2008 · Initiated August 10, 2007

    Recall

    Recall Number
    Z-0288-2008
    Event Number
    45333
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 10, 2007
    Terminated
    April 19, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064

    Reason

    Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.

    Action

    An August 10, 2007, Product Correction letter was provided to all ARCHITECT cSystem and AEROSET System customers. The letter advises that changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the NIST standard 916a. Revised Bilirubin values for the calibrator lot numbers in this recall are attached to the recall notice. Six necessary actions were listed in the recall notice as: 1) Identify the lot numbers of Clinical Chemistry Bilirubin Calibrator(s) currently in use. 2) Discard the value sheet and replace with the appropriate values provided with the recall letter. 3) Enter the revised Bilirubin values. 4) Calibrate the assays. 5) Evaluate your quality control. 6) Evaluate your reference range and any shifts in patient results.

    Distribution

    Worldwide: USA, Canada, Mexico, Guatemala, Puerto Rico, Germany, Hong Kong, Singapore, Australia, New Zealand, Jamaica, Venezuela, Columbia, Ecuador, Chile, Uruguay, Argentina, Brazil, Thailand, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, and El Salvador

    Quantity

    7,033 units total worldwide