FDA warning on home diagnostic kits
This article was originally published in The Tan Sheet
Executive Summary
Pregnancy Test and Rapid HIV Test Kit marketed by the Canadian firm Globus Media are among the unapproved diagnostic products being sold by the company and should not be purchased, FDA says in a Feb. 7 consumer warning. The other six illegal kits are an HCG urine test and tests for syphilis, cocaine, marijuana, amphetamine and dengue fever. Use of the kits may produce false results that could "lead to significant adverse health consequences" if those who test negative do not seek medical treatment or spread a virus to others, the agency notes. The tests have been marketed nationwide through websites. Anyone who has used one of the kits "should be retested using valid test methods," FDA says...
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Global Pharma Guidance Tracker – March 2024
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