BEUDAMED
    FDA Recall Terminated

    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.

    Recall: Z-2157-2017 · Initiated April 24, 2017

    Recall

    Recall Number
    Z-2157-2017
    Event Number
    77145
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 24, 2017
    Terminated
    May 22, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.

    Reason

    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.

    Action

    An Urgent Medical Device Recall letter dated 4/24/17 was sent to customers to inform them that there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. The letter informs the customers of the issue, impact, action, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at Http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the US and Canada, customers outside the U.S. and Canada are instructed to contact their local Beckman Coulter representative.

    Distribution

    Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.

    Quantity

    4880 units total (2119 units in US)