Home News FDA cautions against relying on Cue Health’s COVID tests

FDA cautions against relying on Cue Health’s COVID tests

FDA cautions against relying on Cue Health’s COVID tests

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 provide you with false results and needs to be thrown out.

This comes a number of days after the FDA sent a warning letter to the corporate 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 steadiness of the devices, leading to failure sooner than the 9 months claimed on the product labeling,” the FDA said in a letter to the corporate 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 12 months, the FDA found that the corporate made multiple changes to the tests without authorization.

“The FDA is warning home test users, caregivers, and health care providers not to make use of Cue Health’s COVID-19 Tests as a result of 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’s Cue Health?

Cue Health is an organization 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 corporate’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 unique COVID-19 test that received FDA authorization for those who 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 retest anyone they’ve tested with a Cue test within the last two weeks if they believe 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?

In line with the FDA, Cue Health modified the formulation of the a part of the test that detects SARS-CoV-2. It also updated the test to detect and proper for failures.

Inspectors found documents indicating the changes were intended to affect “overall device performance and particularly device stability” but they were refrained from notifying the FDA. The agency also said that clinical testing of the changes didn’t meet standards.

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


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