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.