FDA logo blue

USH Diagnostics Hit with FDA Warning Letter for Unapproved COVID-19 Tests

August 16, 2021

The FDA has issued a warning letter to Kansas City, Mo.-based USH Diagnostics for marketing unapproved COVID-19 tests.

The company, also known as covidinstanttest.net, was marketing the unapproved tests when the FDA checked two of its websites and various social media sites.

The unapproved products included the COVID-19 Instant Test, the Dual Antibody Rapid Test and the COVID-19 Dual Antibody Test, which were marketed without “approval, clearance or authorization” from the FDA.

The agency also noted that the company was making unauthorized use of the FDA logo in its marketing. The covidinstanttest.net website is currently disabled.

View today's stories