BEUDAMED
    FDA Recall Terminated

    UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.

    Recall: Z-2501-2010 · Initiated February 12, 2010

    Recall

    Recall Number
    Z-2501-2010
    Event Number
    54745
    Firm
    Inverness Medical Professional Diagnostics
    FEI Number
    3003764480
    Product Code
    LCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 12, 2010
    Posted
    September 25, 2010
    Terminated
    May 14, 2012
    Address
    2 Research Way, Princeton, NJ, 08540-6628

    Description

    UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.

    Reason

    Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test.

    Action

    The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.

    Distribution

    Distributed Nationwide and to Australia

    Quantity

    585 kits