The U.S. Food and Drug Administration (FDA) is issuing a Cue Health COVID-19 Test Recall and FDA Warning for home test users, caregivers, and health care providers. The FDA advises against using Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) use and the COVID-19 Test intended for patient care settings due to an increased risk of false results. The FDA has classified Cue Health’s recall of these two COVID-19 tests as Class II and has also revoked the Emergency Use Authorization (EUA) for Cue Health’s tests.
Check your supply of COVID-19 tests, and if you have these Cue Health tests in your center, ensure you do not rely on them for accuracy. This Cue Health COVID-19 Test Recall and FDA Warning serves as a reminder to talk to your provider about obtaining a refund or replacement product.
Stay well and stay informed!