BEUDAMED
    FDA Recall Terminated

    COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System.

    Recall: Z-3263-2011 · Initiated July 11, 2011

    Recall

    Recall Number
    Z-3263-2011
    Event Number
    59726
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GGK
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    July 11, 2011
    Posted
    September 19, 2011
    Terminated
    June 4, 2012
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System.

    Reason

    The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts; could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control.

    Action

    The recall communication was initiated on 08/01/2011 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US customers) to all customers, who purchased Coulter DxH Cell Lyse. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact Beckman Coulter for product replacement. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their Beckman Coulter representative.

    Distribution

    Worldwide Distribution -- Australia, Belgium, Brunei Darussalam, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.

    Quantity

    4913 units total (2245 in US)