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FDA Clears Sysmex XE-2100D Hematology Analyzer for Blood Processing Center Quality Control Release Testing
Date:9/22/2009

mentation by the blood centers. The Intended Use clearance for the Sysmex XE-2100D greatly reduces the validation effort needed prior to placing the XE-2100D into production. This means a significant saving in time, materials and labor, explained Kershaw. No other currently available hematology analyzer has been cleared for such use.

About Sysmex XE-2100D Blood Center Anticoagulant Clearance

The Sysmex(R) XE-2100D Automated Hematology Analyzer is intended for in vitro diagnostic use in clinical laboratories and donor centers on EDTA anticoagulated whole blood.

Also, in blood processing centers the XE-2100D can now be used as a multi-parameter hematology analyzer and for QC release testing of the following post-processed components:

  • Red blood cell components for RBC, HGB and HCT parameters using CPD, CP2D, ACD-A, CPDA-1 as anticoagulants.
  • Platelet components for PLT and MPV parameters using CPD and ACD-A as anticoagulants.

About the Sysmex XE-2100D Automated Hematology Analyzer

The Sysmex XE-2100D Automated Hematology Analyzer utilizes Sysmex's advanced, hydro-dynamically focused, impedance technology and state-of-the-art cell-counting methods to rapidly and accurately measure parameters such as hemoglobin, hematocrit (direct) and platelet count. The analyzer has extended linearity capabilities required for concentrated cell preparations that make up component therapy, eliminating the need for dilution. Sysmex automated hematology analyzers also rank the industry's best in performance and reliability according to IMV Service Trak(TM) independent industry surveys.

About Sysmex America, Inc.

Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical d
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SOURCE Sysmex America
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