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FDA clears analyzer for high-volume transfusion labs


 

ORTHO VISION Max

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Ortho Clinical Diagnostics

The US Food and Drug Administration has granted 510(k) clearance for ORTHO VISION® Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories.

Ortho Clinical Diagnostics developed ORTHO VISION Max for labs conducting more than 50 types and screens per day.

ORTHO VISION Max is now commercially available in the US as well as Europe and Japan.

The launch of ORTHO VISION® Max follows the 2015 release of the ORTHO VISION® Analyzer, an instrument designed for small- to mid-sized transfusion labs.

Together, the analyzers form the ORTHO VISION® platform. According to Ortho Clinical Diagnostics, the platform automates more tests than ever before and takes less time to perform those tests.

The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.

The ORTHO VISION platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.

The platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help blood bank labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.

“Labs are continuously pushed to accomplish more with fewer resources, including staff, and Ortho can now ease those pressures in labs of every size and makeup,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.

“Whether they perform 15 tests per day or 150, the ORTHO VISION platform helps labs better manage their contribution to the overall critical care path.”

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