BEUDAMED
    FDA Recall Terminated

    Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.

    Recall: Z-1305-04 · Initiated June 7, 2004

    Recall

    Recall Number
    Z-1305-04
    Event Number
    29345
    Firm
    Dade Behring Inc. Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    KFF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2004
    Posted
    July 31, 2004
    Terminated
    January 6, 2005
    Address
    Newark, DE, 19702

    Description

    Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.

    Reason

    Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.

    Action

    The recalling firm sent a recalling letter to the direct accounts informing them that the affected lots can not be used for heparin determinations. Direct account were instructed

    Distribution

    The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain

    Quantity

    781 kits