FDA accuses company of distributing unapproved Covid test and using falsified data
3 days ago - By STAT
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...
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