Do Not Use Cue Health COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results.

The FDA issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.

This safety communication provides:

• Recommendations for patients, caregivers, and health care providers.
• Background on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems with Cue COVID-19 tests to the FDA.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).