FDA Warns Against Using Cue Health’s COVID-19 Tests

The United States Food and Drug Administration (FDA) has issued a warning not to use Cue Health’s at-home COVID-19 tests due to an increased risk of false results.

If you have any Cue Health COVID-19 tests lying around in your bathroom cabinet, you’d be wise to throw them out right about now, according to the FDA.

The FDA warned against using these tests Monday following an inspection of Cue Health’s COVID tests. The inspection revealed that the company had made changes to its tests — changes that reduced their reliability in producing an accurate result when detecting the SARS-CoV-2 virus.

As a result, home test users, caregivers, and health care providers are being advised not to use the company’s home and over-the-counter tests, nor their COVID-19 tests intended for patient care settings, as they may produce both false positives and false negatives.

“Do not use any Cue Health COVID-19 Tests for Home and OTC Use that you may still have,” the FDA said in its warning. “Dispose of the entire test cartridge in the household trash.”

Anyone who was recently tested with a Cue Health test and is concerned about the results is advised to speak with their healthcare provider, and anyone who tested negative but still has symptoms is advised to retest using a different COVID-19 test that received FDA authorization.

The FDA is also asking people to report any problems they experience with the Cue Health tests, including suspected false positive or false negative results, using the MedWatch Voluntary Reporting Form.

Healthcare providers are likewise being advised to stop using the tests, retest their patients using a different brand, and report any issues with the tests to the FDA.

The FDA initially issued Emergency Use Authorizations to Cue Health for two COVID-19 tests to be used in healthcare care settings in June of 2020. The company’s at-home test was authorized in March of 2021.

On May 10, 2024, however, the FDA issued a warning letter to Cue Health outlining several issues they found during their inspection of the company’s tests.

“Your firm should take prompt action to address any violations identified in this letter,” the FDA wrote. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

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