BEUDAMED
    FDA Recall Terminated

    COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.

    Recall: Z-2481-2015 · Initiated July 22, 2015

    Recall

    Recall Number
    Z-2481-2015
    Event Number
    71835
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GIF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 22, 2015
    Posted
    August 28, 2015
    Terminated
    December 18, 2015
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.

    Reason

    Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.

    Action

    An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of the US and Canada, are instructed to contact their local Beckman Coulter Representative.

    Distribution

    Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.

    Quantity

    710 units