BEUDAMED
    FDA Recall Terminated

    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304

    Recall: Z-1013-2017 · Initiated December 19, 2016

    Recall

    Recall Number
    Z-1013-2017
    Event Number
    76044
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 19, 2016
    Posted
    January 11, 2017
    Terminated
    May 12, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304

    Reason

    Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.

    Action

    Beckman Coulter sent an Urgent Medical Device Recall letter dated December 19, 2016, to all affected customers to inform them that Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. The letter informs the customers of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the United States and Canada, and outside the United States and Canada, to contact their local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.

    Quantity

    4,657 units total (2,067 units in US)