BEUDAMED
    FDA Recall Terminated

    Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test

    Recall: Z-1374-05 · Initiated July 8, 2005

    Recall

    Recall Number
    Z-1374-05
    Event Number
    32691
    Firm
    Dade Behring Inc.
    FEI Number
    2517506
    Product Code
    GJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 8, 2005
    Posted
    August 16, 2005
    Terminated
    August 10, 2006
    Address
    500 GBC Dr. PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test

    Reason

    sample may exhibit falsely high results

    Action

    On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.

    Distribution

    The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australia, Chile, China, Saudi Arabi, Taiwan, and Uraguay.

    Quantity

    3255 packs