BEUDAMED
    FDA Recall Terminated

    ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.

    Recall: Z-1203-06 · Initiated June 2, 2006

    Recall

    Recall Number
    Z-1203-06
    Event Number
    35604
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    LLH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2006
    Posted
    July 4, 2006
    Terminated
    February 16, 2012
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    Description

    ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.

    Reason

    The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.

    Action

    The recalling firm sent a recall letter dated 6/2/06 to their customers.

    Distribution

    Nationwide.

    Quantity

    704