Ortho Clinical Diagnostics Receives 510(k) Clearance for ORTHO VISION™ Analyzer, Making it Commercially Available in the United States

Ortho Clinical Diagnostics Receives 510(k) Clearance for ORTHO VISION™ Analyzer, Making it Commercially Available in the United States

Aug 18, 2015

Advanced System Fully Automates Immunohematology Testing, Responds to Unique Challenges of Each Lab 

RARITAN, NJ – August 18, 2015 – Ortho Clinical Diagnostics today announced that it obtained 510(k) clearance for the ORTHO VISIONTM  Analyzer, a highly interactive, fully automated analyzer for transfusion medicine laboratories. The ORTHO VISIONTM Analyzer for Ortho ID-MTSTM Column Agglutination Technology is now commercially available in the United States and Puerto Rico.

Although transfusion medicine has evolved to enhance safety and establish critical efficiencies, today’s automation solutions lack the ability to anticipate and respond to individual user needs and ever-changing conditions within the laboratory. The ORTHO VISIONTM Analyzer’s unique pairing of secure monitoring technologies and dynamic work flow management is an advance that offers labs the ability to address unpredictable demands when needed and have confidence in the results.

"With the launch of the ORTHO VISIONTM  Analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods," said Robert Yates, chief operating officer, Ortho Clinical Diagnostics. "Lab professionals are required to provide results quickly in spite of the continuous strain on resources. The ORTHO VISIONTM  Analyzer fits into our broader portfolio of integrated solutions that empower our customers to respond to these growing pressures and help contribute to delivering the best patient care."

Designed with secure monitoring technologies for safety checks and balances, the ORTHO VISIONTM  Analyzer gives transfusion medicine professionals the ability to track critical steps in the immunohematology testing process. Through Ortho Clinical Diagnostics’ proprietary Intellicheck® Technology, the ORTHO VISIONTM  Analyzer verifies and documents diagnostic checks throughout the testing process, while e-Connectivity® Technology provides 24/7 remote data tracking that monitors instrument performance while maximizing uptime. Laboratory personnel can also log on anytime, anywhere to collaborate on interpreting results in real time for an extra level of confidence.

"The ORTHO VISIONTM  Analyzer eliminates the tradeoffs blood bankers are typically forced to make. Now lab personnel will be able to focus on prioritizing tests as they are requested, including STATs, which re-establishes a natural workflow," said Heidi Casaletto, head of transfusion medicine at Ortho Clinical Diagnostics. "This helps decrease time to results and drives productivity."

Building on its market leadership position, Ortho Clinical Diagnostics is reinforcing its commitment to the transfusion medicine industry with innovations such as the ORTHO VISIONTM  Analyzer, designed to meet the needs of labs and their patients.

A version of the ORTHO VISIONTM  Analyzer is already commercially available in Europe, Japan, Latin America, Canada and Australia.

About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics delivers high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visitwww.orthoclinical.com.


Ortho Clinical Diagnostics
Kristie Bouryal, Chief Corporate Brand and Communications Officer
T: +1 908 218 8768

ORTHO VISIONTM  Analyzer, the ORTHO VISIONTM  Analyzer logo and Intellicheck® are trademarks of
Ortho Clinical Diagnostics
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