BEUDAMED
    FDA Recall Terminated

    ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-1399-05 · Initiated August 7, 2005

    Recall

    Recall Number
    Z-1399-05
    Event Number
    32895
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 7, 2005
    Posted
    August 24, 2005
    Terminated
    March 27, 2006
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.

    Action

    Abbott notified their affiliates in all eight countries via e-mail on 8/7/05. 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 positive results, and were requested to return any remaining inventory of the affected lots to Abbott in Germany.

    Distribution

    This product is not distributed in the U.S. It was distributed internationally to Canada, Germany, Honduras, Nicaragua, the Bahamas, the Philippines (via Singapore), New Zealand, and Uruguay

    Quantity

    3049 kits