SAN DIEGO (KSWB/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests manufactured by a California-based health care company.
Cue Health, headquartered in San Diego, received FDA approval early in the pandemic for two COVID-19 tests to help people detect if they were infected with the virus.
The first test, intended for healthcare use, was approved on June 10, 2020. The at-home, over-the-counter test was approved on March 5, 2021.
However, the FDA sent a warning letter to the company last week after an inspection found that Cue Health had made some changes to the tests and reduced their reliability.
“The evidence obtained during the inspection indicates that your company made several changes to your EUA-approved devices and made these changes without FDA approval, in accordance with the terms of authorization,” the letter said.
On Monday, the FDA told the public, health care providers and healthcare providers to do so has Cue Health's COVID-19 tests due to an increased risk of false results.
The agency instead recommends retesting with a different brand approved by the FDA if patients have received a negative result on the Cue Health test and are still experiencing symptoms consistent with COVID-19.
The FDA added that if the tests were conducted more than two weeks ago and a patient shows no symptoms of a current COVID-19 infection, no new testing is needed.
