First and Only Automated Hematology Analyzer FDA-Cleared for Residual WBC Counting

By LabMedica International staff writers
Posted on 16 Jun 2022

Blood component quality is key in transfusion medicine and blood product manufacturing. Now, the first and only automated hematology analyzer to be FDA-cleared for residual white blood cell counting (WBC) counting is a holistic solution that offers accurate cell counts on products that are key to blood centers and blood banks.

Sysmex America, Inc. (Lincolnshire, IL, USA) has received FDA clearance for the addition of residual white blood cell counting to its XN-10 Automated Hematology Analyzer with Blood Bank mode. 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.


Image: XN-10 automated hematology analyzer with blood bank mode (Photo courtesy of Sysmex)

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. Available as a single module (XN-1000BB) or twin co-primary analyzers (XN-2000BB), the scalable hematology analyzer can 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.

“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.”

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Sysmex America, Inc. 


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