FDA clears Sysmex America's XT-4000i Automated Hematology Analyzer

Sysmex America, Inc., a leading medical diagnostic instrument manufacturer and information systems developer, today announced that its Sysmex XT-4000i™ Automated Hematology Analyzer has been cleared by the United States Food and Drug Administration (FDA).  The Sysmex XT-4000i provides 34 parameters, including the advanced clinical parameters, IG (Immature Granulocyte) and RET-He (Reticulocyte Hemoglobin Equivalent) and a Body Fluid specific mode.  It utilizes Sysmex's patented fluorescent flow cytometry and advanced cell counting methods to deliver rapid, reliable results essential in patient diagnosis and therapeutic monitoring.

"With FDA's clearance of the Sysmex XT-4000i, we are truly in a unique position to offer a portfolio of hematology products that support the needs of small clinics to high-volume clinical laboratories in every sized hospital or Integrated Delivery Network in the nation.  Additionally, the Sysmex XT-4000i offers the reliability and standardization of Sysmex's patented flow cytometry technology platform, thereby enhancing efficiency and improving productivity without sacrificing quality or accuracy," said John Kershaw, President & CEO, Sysmex America, Inc.

The new Sysmex XT-4000i automated hematology analyzer's IG parameter provides the reliable detection and quantification of circulating immature granulocytes that may be used by physicians as an early indicator of acute infection, inflammatory response or myeloproliferative disorder.  Its RET-He parameter, which quantifies the hemoglobin content of reticulocytes, is an established parameter in the National Kidney Foundation's KDOQI (Kidney Disease Outcomes Quality Initiative) guidelines for assessing the initial iron status of patients with chronic kidney disease on hemodialysis as well as I.V. iron replacement in these patients.


Sysmex America, Inc.


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