BEUDAMED
    FDA Recall Terminated

    Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054

    Recall: Z-0269-06 · Initiated September 20, 2005

    Recall

    Recall Number
    Z-0269-06
    Event Number
    33616
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2005
    Posted
    December 6, 2005
    Terminated
    November 2, 2006
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054

    Reason

    The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.

    Action

    On September 20, 2005, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the recall. In February, the firm expanded its recall to all lots as a result of having identified an additional failure in a different lot.

    Distribution

    Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to assess their inventory of DILUENT 08H17-01 and 99226-01 to determine if they had any of the affected lots in their possession. Foreign countries include: Canada, Columbia, Uruguay, Germany, Barbados, Bermuda, Cayman Islands.