FDA issues warning against using Cue Health’s COVID-19 tests due to a heightened risk of false positive results.

The FDA has issued a warning against using Cue Health’s over-the-counter COVID-19 tests due to a heightened risk of false positive results. The agency advises both consumers and healthcare providers to discontinue using these tests. This recommendation follows unauthorized modifications made by Cue Health to their test formulas and device firmware without FDA approval. Originally approved for emergency use in 2020 and 2021, the tests involved a molecular method using nasal swabs and provided results via smartphone in 20 minutes. The FDA has halted Cue Health’s distribution until new authorization is obtained, urging those with defective tests to report issues via the MedWatch Voluntary Reporting Form. Cue Health is currently assessing the FDA’s letter and planning a response, with their stock price dropping significantly as a result