BEUDAMED
    FDA Recall Terminated

    Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Recall: Z-1658-2010 · Initiated February 4, 2010

    Recall

    Recall Number
    Z-1658-2010
    Event Number
    55176
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 4, 2010
    Posted
    May 26, 2010
    Terminated
    September 2, 2014
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Reason

    Issue 1: The system will substitute or omit the characters # @ 1 \ ] ' ( I ) - when the instrument is configured in a language other than English, Chinese or Japanese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456'. Issue2: The characters 7 " and * (question mark, quotation mark, and asterisk) used as part

    Action

    Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

    Distribution

    Distributed Nationwide and Canada.

    Quantity

    56 units