Do not use Cue Health COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 05/13/2024 02:40 PM EDT

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U.S. Food and Drug Administration, Center for Devices and Radiological Health, Safety Communication

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.

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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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