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    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).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·August 8, 2016

    UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 1, 2015

    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 1, 2015

    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GIF·April 13, 2015

    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·September 24, 2013

    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

    FDA Recall
    Terminated ·Beckman Coulter, Inc.·Product code GKZ·October 7, 2019

    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 1, 2015

    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code BSZ·August 4, 2016

    UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KPA·December 13, 2011

    UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CKG·December 13, 2011

    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GIF·August 25, 2014

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

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JCB·November 8, 2013

    DxH 600 Coulter Cellular Analysis System, Catalog No. B23858

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 19, 2016

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

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·December 19, 2016

    Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JCB·November 8, 2013

    COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L). The COULTER DxH Cell Lyse is an erythrocyte lytic agent used for quantitative determination of hemoglobin, enumeration of NRBC, and counting and sizing leukocytes on UniCel DxH 800 Coulter Cellular Analysis System.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GGK·July 11, 2011

    UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·November 8, 2013

    UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·November 8, 2013

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·February 11, 2011

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·February 11, 2011