BEUDAMED
    FDA Recall Terminated

    Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.

    Recall: Z-1018-2010 · Initiated October 7, 2009

    Recall

    Recall Number
    Z-1018-2010
    Event Number
    54131
    Firm
    Mainline Technology, Inc.
    FEI Number
    1000160426
    Product Code
    LCX
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    October 7, 2009
    Posted
    March 8, 2010
    Terminated
    February 4, 2011
    Address
    3985 Research Park Dr, Ann Arbor, MI, 48108-2282

    Description

    Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.

    Reason

    Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates.

    Action

    Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.

    Distribution

    Worldwide Distribution -- United States, Belgium and Switzerland.

    Quantity

    Information not provided.