FDA Accuses Company of Distributing Unapproved Covid Test and Using Falsified Data

June 10, 2021

(STAT News) – The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance. The agency announced a “Class 1 recall” — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States. (Read Full Article)