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FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media

or "The Home Access Express HIV-1 Test System" is manufactured by Home Access Health Corporation and allows blood samples to be taken at home which people then send to a laboratory for testing. No home-use test kits intended for diagnosing syphilis and dengue fever are approved for sale in the U.S.

The FDA has issued an import alert which alerts FDA field personnel to the possible importation of the Globus Media devices, provides guidance as to their detention and refusal of admission into the U.S., and also advises U.S. Customs officials about these products.


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Source:FDA


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