BEUDAMED
    FDA Recall Terminated

    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.

    Recall: Z-1616-2015 · Initiated April 13, 2015

    Recall

    Recall Number
    Z-1616-2015
    Event Number
    71045
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GIF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 13, 2015
    Posted
    May 15, 2015
    Terminated
    October 1, 2015
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.

    Reason

    Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.

    Action

    An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent. The letter informs customers that Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution -- Argentina; Brazil; Brunei Darussalam; Canada; Chile; Colombia; Hong Kong; India; Lebanon; Macao; Mexico; Panama; Philippines; Qatar; Singapore; Taiwan; Thailand; Trinidad and Tobago; United States, including Puerto Rico; and Uruguay.

    Quantity

    829,888 units total (659,584 units in US)