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Ortho Clinical’s automated blood analyzer gets FDA approval

MDBR Staff Writer Published 24 October 2016

ORTHO VISION Max, a fully automated blood analyzer designed by Ortho Clinical Diagnostics for high-volume transfusion medicine laboratories, has received 510(k) clearance from the US Food and Drug Administration (FDA).

With the clearance, ORTHO VISION Max, which is designed to improve lab efficiency is now commercially made available in the US, Europe and Japan.

Developed for labs that conduct over 50 types and screens each day, it also supports more complex immunohematology testing that includes serial dilutions for titration studies, selected cell antibody identification and reflex tests.

The recently launched ORTHO VISION Max follows the ORTHO VISION Analyzer which was released last year to cater to the needs of small and medium sized transfusion labs.

The two analyzers form the ORTHO VISION platform claimed to streamline workflow while standardizing systems and processes.

ORTHO VISION platform is also said to assist blood bank labs in matching the industry pressure for increased productivity without compromising on operational efficiency.

Ortho Clinical Diagnostics chief operating officer Robert Yates said: “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.

"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."

The ORTHO VISION platform developed in direct collaboration with transfusion medicine specialists and can be used by both individual and multi-site network of hospitals.

Its key advantage is that it allows the transfusion medicine department to process routine samples as well as STAT orders right away and eliminating the waiting time for a complete batch which is otherwise needed to run the instrument.


Image: FDA Clears ORTHO VISION(R) Max Analyzer for High-Volume Transfusion Medicine Labs. Photo: courtesy of PRNewsFoto/Ortho Clinical Diagnostics.