BEUDAMED
    FDA Recall Terminated

    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.

    Recall: Z-1831-2014 · Initiated November 8, 2013

    Recall

    Recall Number
    Z-1831-2014
    Event Number
    67058
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JCB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 8, 2013
    Posted
    June 20, 2014
    Terminated
    December 25, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.

    Reason

    Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

    Action

    An Urgent Product Correction letter, dated 11/08/2013, was sent to all the customers who purchased the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, via phone at (800) 526-7694 in US and Canada. For outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative. Beckman Coulter sent an update on 2/14/14, to inform customers that the recall was expanded to include specific lots of DxH Cleaner.

    Distribution

    Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    12,924 units total (9,733 units in US)