BEUDAMED
    FDA Recall Terminated

    Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100

    Recall: Z-1400-05 · Initiated August 5, 2005

    Recall

    Recall Number
    Z-1400-05
    Event Number
    32959
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 5, 2005
    Posted
    August 24, 2005
    Terminated
    March 7, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100

    Reason

    The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.

    Action

    A Device Correction letter correcting the transposition of the calibrator values dated August 5, 2005, was mailed to all customers receiving the Clinical Chemistry Bilirubin Calibrator, LN 1E66-03, Lot Number 20881M100.

    Distribution

    Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela

    Quantity

    213