Throw out COVID-19 tests made by San Diego company, FDA warns

SAN DIEGO (FOX 5/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests that were manufactured by a company based in San Diego.

Health care company Cue Health received emergency use authorization for two COVID-19 tests from the FDA early on in the pandemic to help people detect whether they have been infected with the virus.

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The test intended for use in health care settings was authorized on June 10, 2020, and the at-home and over-the-counter test received authorization on March 5, 2021.

However, the FDA issued a warning letter to the company last week after an inspection revealed that Cue Health had made some changes to the tests and reduced their reliability.

On Monday, the FDA told the public, caregivers and health care providers to dispose of Cue Health’s COVID-19 tests due to an increased risk of getting false results. Instead, the agency recommends retesting using a different brand that has been authorized by the FDA if one received a negative result on the Cue Health test and still shows symptoms consistent with COVID-19.

The FDA added if testing was performed more than two weeks ago and a patient shows no symptoms of current COVID-19 infection, another test is not needed.

In a statement Monday, Cue Health said it is “currently evaluating the letter and determining its response.”

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