FDA approves new fully automated blood analyzer for high-volume transfusion labs

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that ORTHO VISION® Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories, received 510(k) clearance, signifying its conformity with U.S. Food and Drug Administration regulation. ORTHO VISION Max is now commercially available in the United States, and is also commercially available in Europe and Japan.

The ORTHO VISION® Max launch 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, which builds on Ortho Clinical Diagnostics' proven track record of innovation in the transfusion medicine industry by delivering the only integrated instrument suite that's part of a larger portfolio of products and services. Tailoring to the needs of any facility, the ORTHO VISION platform improves workflow and standardizes systems and processes, helping blood banks labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.

ORTHO VISION Max was developed for labs conducting greater than 50 types and screens per day, and it also supports more complex immunohematology testing such as serial dilutions for titration studies, reflex tests and selected cell antibody identification. The flexibility and responsiveness of the system allow the 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 ORTHO VISION platform's ability to manage unpredictable workflow paired with its standardization benefits improve lab efficiency and, most importantly, patient care.

"Transfusion medicine departments are now focused not only on testing, but on connecting their work to patient outcomes," said Heidi Casaletto, head of transfusion medicine at Ortho Clinical Diagnostics. "A comprehensive portfolio of products operating on a single platform means engaging with one user interface, ordering one set of consumables, one set of process and procedures and streamlining training for everyone in the department. It also means more rapid delivery of actionable results that would increase the efficiency of patient diagnosis and a recommended treatment plan."

Source: Ortho Clinical Diagnostics


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