BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.

    Recall: Z-1425-2012 · Initiated July 9, 2009

    Recall

    Recall Number
    Z-1425-2012
    Event Number
    52748
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    CIG
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    July 9, 2009
    Posted
    April 16, 2012
    Terminated
    March 7, 2014
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.

    Reason

    Abbott Laboratories has issued a recall on the Clinical Chemistry Total Bilirubin due to an under-recovery on one clinical neonatal specimen resulting in a value less than the assay linear limit.

    Action

    Abbott Laboratories plans to release a Product Correction letter to customers instructing customers to follow the steps provided in order to revise their Total Bilirubin assay parameters. The letter explained the reason for the recall, along with the patient impact. Customers were to keep the letter as part of their laboratory records and also forward a copy to any other laboratories that they may have forwarded Total Bilirubin kits. U.S. Customers should contact Customer Service at 1-877-4ABBOTT, if they have questions.

    Distribution

    Worldwide Distribution -- USA, Guatemala, Chile, Brazil, Canada, Germany, Hong Kong, Thailand, Puerto Rico, Australia, New Zealand, Trinidad & Tobago, Bermuda, Curacao, Cayman Island, and Jamaica.

    Quantity

    11,282