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FDA Says Do Not Use Cue Health COVID-19 Tests Due to Possible False Results

In science and medicine, information is constantly changing and may become out-of-date as new data emerge. All articles and interviews are informational only, should never be considered medical advice, and should never be acted on without review with your health care team.

Authored by Dr. Brian Koffman

On May 13th, the US FDA warned home test users not to use Cue Health’s COVID-19 Tests for Home and Over-The-Counter (OTC) Use due to the increased risk of false results.

It’s crucial that if you have any unused cartridges, they should all be promptly and responsibly thrown out. They are safe to put in the regular household trash.

If you have relied on a recent test result, positive or negative, using the Cue test, it’s imperative that you do not consider it reliable and should consult with your healthcare team immediately to determine what further action, if any, is required.

A recent FDA inspection discovered “changes without authorization from the FDA,” which decreased the test’s accuracy.

More information can be found on the FDA website: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication.

You can also report any problem with your test at MedWatch Online Voluntary Reporting Form.

CLL Society is actively seeking additional information and will keep you informed as we learn more.