FDA chides Cue Health for changing its home COVID test, tells consumers to throw them out

The FDA is recommending that anyone who still has any home COVID tests left from Cue Health should throw them away. 

According to the agency, its inspectors discovered that the diagnostics company had made undisclosed changes to its products in the time since receiving a green light from the FDA and that these changes “reduced the reliability of the tests to detect SARS-CoV-2 virus.”

“Do not use any Cue Health COVID-19 Tests for Home and OTC Use that you may still have. Dispose of the entire test cartridge in the household trash,” the FDA wrote in its notice to the public and urged users to take a different test if they previously received a negative result but still have symptoms.

The agency also handed Cue a warning letter late last week, which said the modifications the company made to its tests’ hardware and firmware could result in…
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