FDA warns against using Cue Health COVID tests
Check your cabinets. The U.S. Food and Drug Administration warned consumers and health care professionals Monday that COVID-19 tests from Cue Health may give you false results and should be thrown out.
This comes a few days after the FDA sent a warning letter to the San Diegobased company saying it made multi- ple changes to how SARS-CoV-2 was detected and verified in its tests with- out FDA authorization, something prohibited by the tests’ Emergency Use Authorization agreements.
“These modifications may negatively impact the stability of the devices, resulting in failure earlier than the 9 months claimed on the product labeling,” the FDA said in a letter to the company May 9.
Cue Health received emergency use authorizations from the FDA in 2020 and 2021 to sell two COVID-19 tests, one for home use and one for clinical use, the agency said in a release.
The company specializes in home testing, screening and telehealth services. It claimed in October 2023 that a peer-reviewed clinical study on asymptomatic people found that the company’s COVID-19 test results were comparable to lab-based PCR tests.
But after 10 different inspections of Cue Health’s facilities between Oct. 17 and Nov. 3 last year, the FDA found that the company made multiple changes to the tests without authorization.
Specifically, Cue Health changed the formulation of the part of the test that detects SARS-CoV-2, according to the FDA. It also updated the test to detect and correct for failures.
Inspectors found documents indicating the changes were intended to affect “overall device performance and in particular device stability,” but they were done without notifying the FDA. The agency also said that clinical testing of the changes did not meet standards.
“The FDA is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to this increased risk of false results,” the FDA said Monday.
The agency urged anyone with Cue Health tests to discard them.
If you tested negative with a Cue Health test but still feel unwell, “consider retesting using a different COVID-19 test that received FDA authorization,” the FDA said.
The agency also suggests talking to your health care provider.
Health care professionals are urged to retest anyone they have tested with a Cue test in the last two weeks if they suspect an inaccurate result.
Anyone experiencing problems with the test, including suspected false results, can report it to the FDA.
In its May 9 letter, the FDA asked Cue Health to address the violations or risk seizure, injunction and civil money penalties.