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    COULTER HmX

    FDA UDI
    Beckman Coulter, Inc.·15099590265052·COULTER HmX Hematology Analyzer with Autoloader

    COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

    FDA 510(k)
    FDA Class 2 ·Hematology

    COULTER HmX Pak Regent Kit

    FDA UDI
    Beckman Coulter, Inc.·15099590663810·COULTER HmX Pak Regent Kit

    COULTER HmX Pak Reagent Kit

    FDA UDI
    Beckman Coulter, Inc.·15099590625764·COULTER HmX Pak Reagent Kit

    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

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 13, 2017

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·October 25, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 4, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·March 6, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 16, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·November 29, 2011

    COULTER HMX HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 19, 2011

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·February 10, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 16, 2011

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 14, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 14, 2012

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 16, 2011

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 15, 2011

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·August 19, 2013

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·August 18, 2010

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code GKH·May 31, 2005