FDA Issues Safety Alert Not to Use Cue Health COVID-19 Tests
Per the notice below, the United States Food and Drug Administration (FDA) has issued a safety alert not to use Cue Health COVID-19 tests due to risk of false results.
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).
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