FDA Clears Sysmex Hematology Analyzer for Blood Processing Center QC Release Testing

Sysmex announces that its Sysmex XE-2100D Automated Hematology Analyzer has been cleared by the 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.

"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.

Source: Sysmex