Vitros recall
This article was originally published in The Gray Sheet
Executive Summary
FDA 1announced a Class I recall Jan. 9 initiated by Johnson & Johnson/Ortho-Clinical Diagnostics for its Vitros hepatitis B surface antigen confirmatory kit. An unknown component in the diluting solution used with the test is causing false negative results. The firm sent a letter Dec. 15 instructing customers to discontinue the use of remaining inventory and to review previously reported results...