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FDA Clears Sysmex Hematology Analyzer With Blood Bank Mode

NEW YORK ─ Sysmex America said on Wednesday that it recently received US Food and Drug Administration clearance for its XN-10 Automated Hematology Analyzer with Blood Bank mode, and added the analyzer to its portfolio of hematology testing products.

The XN-10 analyzer supports red blood cell and platelet component testing and provides an automated complete blood count with differential for whole blood samples. The analyzer's XN Blood Bank mode provides precise and rapid cell counts without sample preparation or pre-dilution, Sysmex said.

The XN Blood Bank mode provides accurate cell counts on products that are important to blood centers and blood banks and is intended for use by blood processing centers for quality-control release testing of post-processed components, the firm said.

The hematology analyzer is scalable and may be installed as a tabletop analyzer or placed on wagons.

Lincolnshire, Illinois-based Sysmex America is a regional affiliate of Kobe, Japan-based Sysmex.