FDA: Cue Health COVID tests may return false positive, negative results, so throw them away

Check your cabinets. The U.S. Food and Drug Administration (FDA) warned consumers and healthcare professionals Monday that COVID-19 tests from Cue Health may give you false results and should be thrown out.

This comes a few days after the FDA sent a warning letter to the company saying San Diego-based Cue Health made multiple changes to how SARS-CoV-2 was detected and verified in its tests without FDA authorization, something prohibited by the tests' Emergency Use Authorization agreements.

"These modifications may negatively impact the stability of the devices, resulting in failure earlier than the 9 months claimed on the product labeling," the FDA said in a letter to the company last Thursday.

Cue Health received Emergency Use Authorizations (EUAs) from the FDA in 2020 and 2021 to sell two COVID-19 tests, one for home use and one for clinical use, the agency said in a release. But after 10 different inspections of Cue Health's facilities between Oct. 17 and Nov. 3 last year, the FDA found that the company made multiple changes to the tests without authorization.

"The FDA is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to this increased risk of false results," the FDA said in a press release Monday. The agency urged anyone with Cue Health tests to discard them.

What is Cue Health?

Cue Health is a company specializing in home-testing, screening and telehealth services. It claimed in October 2023 that a peer-reviewed clinical study on asymptomatic people found that the company's COVID test results were comparable to lab-based PCR tests.

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Which Cue Health COVID tests are affected?

• Cue Health COVID-19 Test, for healthcare use

• Cue Health COVID-19 Test for Home and Over The Counter Use, for home use

What should I do if I tested negative with a Cue Health test but still feel bad?

"Consider retesting using a different COVID-19 test that received FDA authorization if you tested negative on the Cue Health COVID-19 Test for Home and OTC Use and still have symptoms," the FDA said. The agency also suggests talking to your healthcare provider.

Healthcare professionals are urged to restest anyone they have tested with a Cue test in the last two weeks if they suspect an inaccurate result.

Anyone experiencing problems with the test, including suspected false results, can report it to the FDA.

What did Cue Health change in its COVID tests?

According to the FDA, Cue Health changed the formulation of the part of the test that detects SARS-CoV-2. It also updated the test to detect and correct for failures.

Inspectors found documents indicating the changes were intended to affect "overall device performance and in particular device stability" but they were done without notifying the FDA. The agency also said that clinical testing of the changes did not meet standards.

In its May 9 letter, the FDA asked Cue Health to address the violations or risk seizure, injunction, and civil money penalties.

This article originally appeared on The Daytona Beach News-Journal: COVID tests from Cue Health may not be reliable, FDA urges against use