SAN DIEGO (KSWB/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests that were manufactured by a California-based health care company.
Cue Health, headquartered in San Diego, received emergency use FDA authorization for two COVID-19 tests early in the pandemic to help people detect if they were infected with the virus.
The first test, intended for use in health care settings, was authorized on June 10, 2020. 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.
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“Evidence obtained during the inspection demonstrated that your firm implemented several changes to your EUA-authorized devices and implemented those changes without authorization from FDA pursuant to the Conditions of Authorization,” the letter states.
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.
The agency instead recommends retesting using a different brand authorized by the FDA if patients received a negative result on the Cue Health test and still show 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.
