Beckman Coulter’s New Hematology Connected Workcell Solution Receives FDA Clearance

Scalable and customized DxH Hematology Workcell helps labs streamline workflow with first pass results accuracy

Beckman Coulter Diagnostics received US Food and Drug Administration (FDA) 510(k) clearance for its UniCel DxH v3.0 software, which supports automated connectivity of the UniCel DxH 800 and DxH Slidemaker Stainer COULTER Cellular Analysis Systems. The UniCel DxH Connected Workcell solution is now available for in vitro diagnostic use. The clearance enables laboratories to connect up to three DxH 800 analyzers to a DxH Slidemaker Stainer to create a customized, scalable workflow solution.

With Beckman Coulter’s new DxH workcells, laboratories in the US can benefit from the efficient workflow management that has been successfully adopted by labs in 18 countries since the DxH v3.0 software was CE Marked in March 2014. With its unique automated sample routing, increased data management capabilities and proven analytical capabilities, the DxH Connected Workcell provides low review rates and first past accuracy in results’ reporting all driven by Beckman Coulter’s exclusive Automated Intelligent Morphology (AIM), a multidimensional, high‐definition flow cytometric technology.

“Beckman Coulter’s UniCel DxH Connected Workcell solution expands on what the advanced technologies behind the DxH 800 started — continuing a legacy of excellence in hematology innovation,” said Arnd Kaldowski, president, Beckman Coulter Diagnostics. “The DxH series further demonstrates how Beckman Coulter offers solutions that help labs go beyond routine testing by automating processes to provide information that improves diagnosis in all areas of the laboratory — from hematology and urinalysis to chemistry and immunoassay.”

In combination with Beckman Coulter’s AIM technology, the workcell’s unique bi‐directional sample transport system, automatically distributes samples between the analyzers, reducing potential delays in sample testing and the reporting of results. The technology also allows for critical STAT samples or body fluids to be added while the system is running, without the need to interrupt routine sample testing.

User‐defined decision rules for auto‐rerun and reflex testing further improve workflow and reduce turnaround time (TAT). User‐defined rules also drive automatic slide preparation and staining, without the need for manual intervention. Data management is also streamlined with information consolidated for order entry, results review (able to handle up to 90,000 results) and Quality Control management (with a storage capacity for 30 control files, each with 150 runs per instrument).

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Image Caption: The UniCel® DxH^TM Slidemaker Stainer COULTER® Cellular Analysis System

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