BEUDAMED
    FDA Recall Terminated

    Unicel DxH 800 Coulter Cellular Analysis System

    Recall: Z-2338-2010 · Initiated February 12, 2010

    Recall

    Recall Number
    Z-2338-2010
    Event Number
    55699
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 12, 2010
    Posted
    September 1, 2010
    Terminated
    September 10, 2010
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Unicel DxH 800 Coulter Cellular Analysis System

    Reason

    The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu

    Action

    The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.

    Distribution

    Throughout the United States and Canada

    Quantity

    53 units in USA and 3 units in Canada