US: A Warning Letter Sent to Three Companies Claiming COVID-19 from Blood Test at Home

US health regulators have clamped down on three companies to sell home blood tests for coronavirus, warning that the products are not shown on a safe and accurate screen for COVID-19.
US: A Warning Letter Sent to Three Companies Claiming COVID-19 from Blood Test at Home

The Food and Drug Administration on Wednesday sent warning letters to the companies, saying their products were illegal as they had not been reviewed by the agency for domestic use.  While the FDA has a handful of tests that allow patients to collect saliva samples at home, the agency has not conducted any tests for full use at home.

The letter stated that it may be risky to conduct tests at home.  As consumers may misinterpret the sample or use the results incorrectly.  Companies targeted by the FDA include Medkit Limited of Hong Kong, Antibodiescheck.com of the United Arab Emirates and Sonrisa Family Dental of Chicago.

The letter to the Chicago company marked an online post promoting the covid test for the entire family in 15 minutes!  Additionally, the company falsely claimed that its products were approved by the FDA.  However, the FDA logo was appropriated without permission.  FDA's Director of Medical Devices, Dr. Jeffrey Shuren, said in a statement that such conduct would not be tolerated by the FDA.

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