FDA warns that Q Health's COVID-19 tests may have inaccurate results

TeaThe Food and Drug Administration warned consumers on Monday not to use Q Health's at-home COVID-19 tests. This comes after the FDA sent a warning letter to the company last week, saying Q was not following the conditions set out in emergency use authorizations for its tests.

The FDA letters say the tests may give false results. Specifically, the agency said the company changed the way it generates, receives, and interprets electrochemical signals within the testing device – the FDA did not authorize such changes. The agency said these changes reduced the stability of the tests and could lead to false results.

The FDA warnings may come near the end of a remarkably bumpy ride for the company. When Q went public in 2021, it was valued at about $3 billion. It supplied tests for the NBA's 2020 “bubble,” leading a Trump administration official to declare that if the test was “good enough for LeBron,” the administration would bring it to the American people — and it made $481 million. Did this in a deal.

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