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Home Access HIV test lacks proper package warnings, Confide inventor contends.

This article was originally published in The Tan Sheet

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."

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