FDA Warns Against an Unauthorized COVID-19 Test from ACON
The FDA has issued an advisory warning people not to use ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test, which is designed for self-testing.
The agency said the test is not authorized, cleared or approved for distribution or use in the U.S., and there is a risk that it may deliver false results.
The FDA said it has not received any reports of adverse health consequences or deaths associated with use of the test.
The company’s Flowflex COVID-19 Antigen Home Test, which the FDA authorized in October 2021, is not affected and can continue to be used, the agency said.