BEUDAMED
    FDA Recall Terminated

    CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

    Recall: Z-0640-2007 · Initiated February 24, 2004

    Recall

    Recall Number
    Z-0640-2007
    Event Number
    37444
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GIF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2004
    Posted
    March 17, 2007
    Terminated
    May 1, 2007
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

    Reason

    Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

    Action

    Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed

    Distribution

    Worldwide Distribution-USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, lA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. and countries of Australia, Argentina, Brazil, Hong Kong, Japan, Korea, Malaysia, Singapore.

    Quantity

    9,800 units