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.