Do Not Use Cue Health COVID-19 Tests Due to Risk of False Results: FDA Safety Communication (05/13/2024)

Summary

Food and Drug Administration (FDA) bulletin sent 05/13/2024 02:40 PM EDT carrying a safety communication titled Do Not Use Cue Health COVID-19 Tests Due to Risk of False Results. It says the FDA issued the 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. It says 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. The communication provides recommendations, background on the issue and the FDA's actions, and instructions for reporting problems.

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“Do Not Use Cue Health COVID-19 Tests Due to Risk of False Results: FDA Safety Communication (05/13/2024).” Original at content.govdelivery.com. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/fda-cue-health-safety-comm-donotuse-govdelivery-2024-40069e04d4/, SHA-256 74131cde230fe91d77b06422087a07eddffc3bc5af8060e2011ba28e9fa3f59d.

Full text

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

If your email program has trouble displaying this email, view as a webpage . 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. Read More 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) . | If your email program has trouble displaying this email, view as a webpage . 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. Read More 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) . | If your email program has trouble displaying this email, view as a webpage . | If your email program has trouble displaying this email, view as a webpage . | 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. Read More 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) . | 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. Read More 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) . | Read More | Read More

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