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Globus Media warning

This article was originally published in The Gray Sheet

Executive Summary

FDA issues import alert for group of unapproved home-use diagnostic test kits marketed by Montreal-based Globus Media following two user complaints associated with the kits. The tests for HIV, syphilis, dengue fever, pregnancy and drug use - sold via Internet sites and distributed throughout the U.S. mainly by overnight services - may not accurately identify the manufacturer, packer or distributor, FDA warns in a Feb. 7 FDA "talk paper"...

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