BEUDAMED
    FDA Recall Terminated

    ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-1392-05 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-1392-05
    Event Number
    31466
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    August 24, 2005
    Terminated
    May 25, 2006
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.

    Action

    Abbott notified their affiliates in all four countries via e-mail on 3/16/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positve results, and were requested to destroy any remaining inventory of the affected lots.

    Distribution

    Canada, Germany, Hong Kong and Australia

    Quantity

    7607 kits