Executive Summary

HOME ACCESS HIV TEST KIT LACKS MANY OUTSIDE PACKAGE WARNINGS that FDA required of the Confide diagnostic HIV blood test formerly marketed by J&J, Elliot Millenson, the inventor of Confide, contends in a Sept. 8 letter to FDA that follows up on a Feb. 27 citizen petition. With regard to the purported lack of adequate outside warnings on Hoffman Estates, Ill.-based Home Access' blood test for HIV-1, Millenson, of Far Hills, N.J., says there are "no warnings about use by people with clotting disorders, no age use recommendations and no indication the [Home Access] kit is intended for self use."