BEUDAMED
    FDA Recall Terminated

    CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.

    Recall: Z-2352-2010 · Initiated April 16, 2010

    Recall

    Recall Number
    Z-2352-2010
    Event Number
    56309
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2010
    Posted
    September 2, 2010
    Terminated
    December 6, 2010
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.

    Reason

    Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.

    Action

    Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.

    Distribution

    Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.

    Quantity

    69 units total