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Health Warning

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 Innova Sars-CoV-2 Antigen Rapid Qualitative Test is a main pillar of the UK’s test and trace system, with more than a billion tests supplied so far in contracts worth around £3bn.

As a result, Innova, a US diagnostics firm, recently announced that it is ramping up its UK operations by opening a factory in Wales, which will produce millions of its LFTs per day.

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.

“Our inspection revealed that the SARS-CoV-2 Antigen Rapid Qualitative Test has been distributed in the United States without marketing approval, clearance, or authorization from FDA,” the agency wrote.

Its decision raises significant pressure on the UK government over its mass use of Innova’s LFT and comes as the British Medicines and Healthcare products Regulatory Agency (MHRA) is considering whether to extend the product’s licence.

https://www.independent.co.uk/news/h...-b1864018.html

https://www.statnews.com/2021/06/10/...alsified-data/