BEUDAMED
    FDA Recall Terminated

    White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-1103-2008 · Initiated December 19, 2007

    Recall

    Recall Number
    Z-1103-2008
    Event Number
    46296
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GGK
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 19, 2007
    Posted
    May 14, 2008
    Terminated
    July 2, 2008
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064

    Reason

    Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

    Action

    Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.

    Distribution

    Worldwide Distribution including USA states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI and WV, and countries of: Argentina, Australia, Brazil, Canada, Germany, Hong Kong, Japan, Singapore, South Korea and Venezuela.

    Quantity

    Product was distributed in the follow amounts: 1,199 botttles of lot code 51749i2; 1,150 bottles of lot code 1574i2, 1,150 bottles of lot code 56675i2