Important Notice: Avoid Using Cue Health's COVID-19 Testing Kits

Important Notice: Avoid Using Cue Health’s COVID-19 Testing Kits

Important Notice: Avoid Using Cue Health's COVID-19 Testing Kits

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Update: October 16, 2024

The FDA has categorized the recall of Cue Health’s two COVID-19 tests as Class II and has rescinded the Emergency Use Authorization (EUA) for these tests. Further details can be found in the FDA Actions.

Date Issued: May 13, 2024

The U.S. Food and Drug Administration (FDA) has issued a warning to users of home tests, caregivers, and healthcare providers not to utilize Cue Health’s COVID-19 Tests designed for Home and Over-the-Counter (OTC) use due to a greater potential for false results.

Advice for Home Test Users and Caregivers

  • Do not utilize any Cue Health COVID-19 tests for Home and OTC use that might still be in your possession. Dispose of the complete test kit in the general trash.
  • If you have been tested using the Cue Health COVID-19 Test for Home and OTC Use and have concerns regarding your results, consult your healthcare provider.
  • If you encountered a negative result with the Cue Health test but continue to exhibit symptoms, consider retesting with an FDA-authorized alternative.
  • Report any issues you face with the Cue Health COVID-19 Test for Home and OTC Use to the FDA, including any suspected false positives or false negatives. For guidance, see Reporting Problems with Your Test.

Guidelines for Healthcare Providers

  • Do not use any remaining Cue Health COVID-19 Tests. Dispose of them properly in your regular waste.
  • If you believe an inaccurate result was produced by the Cue COVID-19 Test, consider retesting patients with another FDA-approved test. No retesting is needed if results were from over two weeks ago and there is no suspicion of current infection.
  • Inform the FDA about any issues related to the Cue Health COVID-19 Test, including suspected inaccuracies. Additional information is available at Reporting Problems with Your Test.

FDA Actions (Updated October 16, 2024)

As of October 15, 2024, the FDA has designated Cue Health’s voluntary recall of their two COVID-19 tests as a Class II recall, indicating that use of these products may lead to temporary or reversible harm, though serious consequences are unlikely.

On October 9, 2024, the Emergency Use Authorizations for both Cue Health’s COVID-19 tests were revoked. The Cue COVID-19 Test and the Cue COVID-19 Test for Home and OTC Use were both affected.

The FDA issued a Warning Letter to Cue Health on May 10, 2024, highlighting that an inspection revealed modifications that lowered the reliability of their tests for detecting the SARS-CoV-2 virus. This led to the warning against the use of Cue Health’s COVID-19 Tests.

The FDA initially provided Emergency Use Authorizations for Cue Health’s two COVID-19 tests, designed to identify SARS-CoV-2 genetic material in nostrils. The first test got its EUA on June 10, 2020, for point-of-care use, while the second test received its EUA on March 5, 2021, for home use.

The FDA will keep the public updated as more significant information arises.

Reporting Issues with Your Device

If you believe you encountered an issue with your device, the FDA urges you to report the issue via the MedWatch Voluntary Reporting Form.

Healthcare personnel in regulated facilities should adhere to the reporting processes set by their establishments.

Have Questions?

If you need further assistance, reach out via email at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.