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

MUNDELEIN, Ill., Sept. 22 /PRNewswire/ -- Sysmex, a global leader in medical diagnostic testing equipment and information systems technology, today announced that its Sysmex XE-2100D Automated Hematology Analyzer has been cleared by the United States Food and Drug Administration (FDA) for blood processing center Quality Control release testing of post-processed red blood cell and platelet components collected using a variety of anticoagulants. Historically, the Sysmex XE-2100D had been cleared for in vitro diagnostic use in clinical laboratories and donor centers as a multi-parameter hematology analyzer for whole blood samples using EDTA anticoagulant. Sysmex is the only original equipment manufacturer to receive FDA cleared anticoagulant Intended Use claims for the Blood Center/Blood Bank market that addresses Quality Control needs, said John Kershaw, CEO, Sysmex America, Inc.

"The nation's blood centers play a critical role in servicing the blood transfusion needs of hospitals across the country. As a best-in-class hematology instrument provider, Sysmex continued development based on blood center customer input. We invested the time and money necessary to conduct the extensive studies required by the FDA to achieve this clearance milestone. The ability to use the XE-2100D with these anticoagulants enables blood centers to meet the FDA's rigorous manufacturing classification demands. It streamlines the validation and documentation process necessary to meet those requirements, providing the potential for improving efficiency and labor utilization," said Kershaw.

Since blood centers are classified as manufacturing organizations, they are highly regulated by the FDA. All instruments and products are to be used according to the manufacturer's intended use and instructions. Any deviation from any of the manufacturers' intended use statements requires extensive validation and documentation 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 diagnostics, automation and information systems. Serving customers for over 40 years, Sysmex focuses on extending the boundaries of diagnostic science while providing the management information tools that make a real difference in clinical and operational results for people worldwide. For more information about Sysmex, please visit www.sysmex.com/usa.


'/>"/>
SOURCE Sysmex America
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Global Gene Map Clears New Milestone
2. FDA Clears MDN-CGS(R) Intravenous Insulin Dosing Software
3. American Medical Association Clears Path for Adenoviral Conjunctivitis - Pink Eye - Detector
4. Congress Clears the Way for National CPR and AED Awareness Week
5. FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
6. ClearScript Offers Innovative Medication Therapy Management Program to Employee Health Plans
7. Alzheimers vaccine clears plaque but has little effect on learning and memory impairment
8. Genetic Information Nondiscrimination Act clears Senate
9. Dutch Authorize Manufacture of Vaccinogens New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial
10. FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
11. FDA Clears the DPL (Deep Penetrating Light) Therapy System for Over-the-Counter - Home Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... Worth, TX (PRWEB) , ... October 13, 2017 ... ... financial planning agency serving communities in the greater Dallas, Miami, and Raleigh regions, ... young boy fighting to overcome a rare and deadly chromosome abnormality. , After ...
(Date:10/13/2017)... ... ... While it’s often important to take certain medications during the night, finding ... identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX to ... the need to turn on a light when taking medication during the night, allowing ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... ... , ... Apple Rehab Shelton Lakes , which specializes in the delivery ... as part of a disaster drill on October 3rd. , Apple Rehab participated with ... Manager, as well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for ... for action towards gender equality at their inaugural Summit in New York City in ... reached a social audience of over 3 million. To watch the Mobilize Women video, ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Oct. 2, 2017  AllianceRx Walgreens Prime, the combined ... Walgreens and pharmacy benefit manager Prime Therapeutics LLC (Prime), ... which included the unveiling of new signage at its ... well as at a few other company-owned facilities across ... to patients, some of whom will begin to see ...
(Date:9/28/2017)... , Sept. 28, 2017 Hill-Rom Holdings, Inc. ... earnings conference call and webcast on Friday, November 3, ... (EDT) and ending at approximately 8:30 a.m. (CDT) / ... the company,s 2017 financial performance and guidance for 2018, ... initiatives to enhance operational performance, and long-range financial outlook ...
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017 /PRNewswire/ ... health and big data solutions, today announced that its MyDario product is ... your local TV listings for when The Dr. Oz Show airs in ... The nine-time ... month. ...
Breaking Medicine Technology: