FDA issues warning for Cue Health COVID-19 tests

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The U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare providers not to use Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care (POC) settings due to an increased risk of false results.

Both tests received emergency use authorizations from the FDA -- the Cue Health COVID-19 Test for use in POC settings on June 10, 2020 and the Cue Health COVID-19 Test for Home and Over-the-Counter Use on March 5, 2021.

However, the FDA issued a warning letter to Cue Health on May 10 after an inspection revealed that the company made changes to the tests without the FDA's authorization. In the letter, the FDA noted that the subsequent acceptable quality level being used by Cue "is not sufficient to ensure that tests released for distribution have the analytical and clinical performance claimed in the authorized labeling. The release of products that fail to meet their claimed performance could lead to an increase in false positive results."

The advice given to both home users and healthcare providers is that they do not use any Cue Health COVID-19 tests they may have and to dispose of the entire cartridge in their household trash or general waste disposal. Furthermore, anyone tested with a Cue Health COVID-19 test who may have concerns about receiving a false negative should consider testing or being retested with a different FDA-authorized test, particularly if they still have symptoms. The FDA noted that there is no need to retest if testing was performed more than two weeks prior and there is no reason to suspect current COVID-19 infection.

Additionally, the FDA requested that consumers and healthcare providers report any problems they experience with the Cue Health COVID-19 tests, including suspected false-positive or false-negative results.

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