FDA warns about using over-the-counter COVID-19 tests from Cue Health
Nasal testing is the manner in which most people check for COVID-19 infection. File Photo by Debbie Hill/UPI | License Photo
The Food and Drug Administration, citing a increase of false results. advised consumers Monday not to use over-the-counter COVID-19 tests by Cue Health and to throw them out.
The FDA issued a warning letter Thursday to the California-based company over findings of a inspection in October and November that shortcomings with the tests, and it advised caregivers and health care providers what steps to take with unused tests.
“Evidence obtained during the inspection demonstrated that your firm implemented several changes” to their devices “and implemented those changes without authorization from FDA pursuant to the Conditions of Authorization,” according to the warning letter to Cue Health CEO Clint Sever.
The inspection had revealed that the San Diego company was no longer in compliance with certain conditions of authorization for its product.
The FDA first authorized the Cue Health COVID-19 Test in June 2020, “granted revisions to the authorized labeling on Aug. 20, 2020, and subsequently reissued the emergency use authorization in its entirety on March 26, 2021.”
The FDA said Cue Health has 15 days to address “specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.”