BEUDAMED
    FDA Recall Terminated

    American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

    Recall: Z-0779-2007 · Initiated February 28, 2007

    Recall

    Recall Number
    Z-0779-2007
    Event Number
    37762
    Firm
    American Diagnostica, Inc.
    FEI Number
    1220602
    Product Code
    GIR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2007
    Posted
    May 3, 2007
    Terminated
    July 6, 2016
    Address
    500 West Ave, Stamford, CT, 06902-6360

    Description

    American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

    Reason

    Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

    Action

    American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.

    Distribution

    Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.

    Quantity

    249 kits