Sysmex America receives FDA clearance for residual white blood cell counting

June 15, 2022
Sysmex America, Inc., a diagnostic solutions company offering hematology, urinalysis, information systems and flow cytometry testing technology for optimal clinical laboratory performance, has received FDA clearance for the addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode, according to a news release.

Sysmex America, Inc., a diagnostic solutions company offering hematology, urinalysis, information systems and flow cytometry testing technology for optimal clinical laboratory performance, has received FDA clearance for the addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode, according to a news release.

This is the first and only automated hematology analyzer to be FDA-cleared for residual WBC counting. The latest analyzer supports red blood cell (RBC) and platelet (PLT) component testing along with residual white blood cell counting in a single sample aspiration, providing blood processing centers with increased efficiency, consistency, and accuracy.

Blood component quality is key in transfusion medicine and blood product manufacturing. Sysmex America’s XN-10 with Blood Bank mode is a holistic solution that offers accurate cell counts on products that are key to blood centers and blood banks. With no sample preparation or pre-dilution required, the XN-10 with Blood Bank mode provides precise and rapid cell counts for greater confidence in blood product quality.

The XN-10 with Blood Bank mode features analysis of blood components with four different selectable profiles – two profiles for red blood cell concentrates and two profiles for platelet concentrates.

“Sysmex America’s XN-10 Automated Hematology Analyzer with Blood Bank mode is a holistic solution that covers donors, patients and blood components,” said Andy Hay, Chief Executive Officer of Sysmex America. “The XN-10’s standardized, consistent, and automated assessment of blood product quality ensures patient safety.”

Available as a single module (XN-1000BB) or twin co-primary analyzers (XN-2000BB), the scalable hematology analyzer may be installed as a tabletop analyzer or placed on wagons, and either model may be made even more efficient with the addition of the RU-20 reagent unit.

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