BEUDAMED
    FDA Enforcement Class II Terminated

    Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality

    Recall: Z-3114-2017 · Reported September 13, 2017

    Enforcement

    Recall Number
    Z-3114-2017
    Event ID
    77830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 13, 2017
    Initiation Date
    June 26, 2017
    Classification Date
    September 7, 2017
    Termination Date
    September 14, 2023
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality

    Reason

    Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.

    Code Info

    Catalog Number(s): HMX CP - 178832, 178833, 178834, A91062, A90994; HmX AutoLoader - 6605522, 6605523, 6605524; All software versions.

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.

    Quantity

    3326 units