BEUDAMED
    FDA Recall Terminated

    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).

    Recall: Z-2732-2016 · Initiated August 8, 2016

    Recall

    Recall Number
    Z-2732-2016
    Event Number
    74912
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 8, 2016
    Posted
    September 2, 2016
    Terminated
    April 29, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).

    Reason

    There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.

    Action

    An Urgent Medical Device Recall letter dated 8/8/16 was sent to all customers who purchased the Unicel DxH 800 and DxH 600 Coulter Cellular Analysis System to inform them that there is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. 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: http://www.beckmancoulter.com/customersupport/support; 800-526-7694 in the US and Canada; outside the US and Canada, contact local Beckman Coulter representative.

    Distribution

    Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.

    Quantity

    5,282 units total (2,877 units in US)