FDA Medical Bulletin * Summer 1999 * Final Issue Lyme Disease Test Kits: Potential for Misdiagnosis By S. Lori Brown, Ph.D., M.P.H., Sharon L. Hansen, Ph.D., John J. Langone, Ph.D., Nancy Lowe, M.A., and Nancy Pressly, B.S. Engr., Center for Devices and Radiological Health The Food and Drug Administration (FDA) is concerned about the potential for misdiagnosis of Lyme disease based on the ...