FDA Warns Against Unauthorized COVID-19 Test from SD Biosensor
The FDA has issued an advisory notice urging consumers not to use in-vitro diagnostics company SD Biosensor’s Standard Q COVID-19 Ag home test.
The agency said it is concerned about the risk of false results from the test, which is not authorized, cleared or approved by the FDA for distribution or use in the U.S.
On Jan. 31, the South Korea-based company announced a recall of the test in the U.S., noting that the test kits were illegally exported to the U.S.
The FDA said it has not received reports of any adverse events or deaths associated with use of the Standard Q test.