Hematology Analyzer Enables QC Testing of Postprocessed Blood Components

The analyzer has extended linearity capabilities required for concentrated cell preparations that make up component therapy, eliminating the need for dilution. Sysmex XE-2100D has been cleared by the United States Food and Drug Administration (FDA; Silver Spring, MD, USA) for blood processing center Quality Control release testing of postprocessed red blood cell and platelet components using different anticoagulants.

Blood centers are classified as manufacturing organizations and are therefore 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 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 John Kershaw, CEO, Sysmex America, Inc.

Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), 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.

Related Links:
Sysmex America, Inc.
United States Food and Drug Administration