Colleen Murphy is a senior editor at Health. To help, the FDA has a list on their website of all at-home tests that have been authorized for emergency use. The Ellume COVID-19 Home Test, which is performed via a nasal swab, received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for people ages 2 and up back in December 2020, making it the first over-the-counter, fully at-home diagnostic test for COVID-19 to receive such an authorization. According to a company spokesperson, Ellume has investigated and identified the cause of the inaccurate tests and has put in place additional controls to ensure the issue is resolved. Cookies collect information about your preferences and your devices and are used to make the site work as you expect it to, to understand how you interact with the site, and to show advertisements that are targeted to your interests. But again, if you buy your test from a reputable placeor order it directly from the governmentyou should be able to trust your purchase. The Cleveland County Health Department will no longer issue the at-home COVID-19 test kit Ellume as it has been recalled by the manufacturer. The BD Veritor At-Home COVID Test: Everything You Should Know, According to Infectious Disease Experts, The Ellume COVID-19 Home Test Is the First FDA-Approved Rapid Test That Doesn't Need a Prescription, Our 8 Top Picks for At-Home HIV Tests to Help You Maintain Your Sexual Health, Insurance Companies Are Now Required to Cover Up to 8 At-Home COVID Tests a MonthHere's How to Take Advantage, Our Top Picks for At-Home Herpes Tests to Help You Address Your Sexual Health, Luciras Over-the-Counter COVID-19 and Flu Test Receives FDA Authorization, Test Your Fertility and Motility with these At-Home Sperm Tests, SD Biosensor, issues notification of voluntary recall of Standard Q COVID-19 Ag home test. Is your cough due to COVID-19, or perhaps the seasonal flu, allergies, RSV, or a cold? home COVID tests recalled due to false positive Experts warn these recalls are crucial for both personal and public health. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Both plaintiffs bought kits that delivered positive results, disrupting their travel plans, only for other tests to find they were negative. Although Ellume touted the reliability of the at-home tests, claiming, for instance, that they demonstrated 96 percent accuracy in clinical studies, the tests were essentially unusable because certain production lots supposedly produced higher than acceptable false positive results due to a manufacturing issue, the lawsuit relays. She is also a fact-checker and contributor for Popular Science. Ellume is one of many companies that have received FDA approval for at home COVID-19 tests. Itchy Throat: Could It Be COVID-19 or Something Else. PORTLAND, Ore. (KOIN) The Ellume brand of at-home COVID-19 tests is recalling a number of kits after an increased number of false-positive test results. Grace Wade is an associate editor for Health.com. We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans, Dr. Jeffrey E. Shuren, the director of the FDAs Center for Devices and Radiological Health, said in a statement in October. COVID-19 "The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result.". You can review and change the way we collect information below. Consumers who did not get a second, confirmatory test after testing positive with a recalled Ellume test should be aware their test result could have been wrong, the company said. Its too soon, so youll have to wait several days before you do it in order to get a more reliable result, he said. Four rapid antigen testssometimes known as at-home COVID-19 testshave been recently recalled by the FDA. Ellume goes broke. CNN More than 2 million of Ellumes at-home Covid-19 tests have been recalled by the company due to higher-than-acceptable false positives. Please download the PDF to view it: Download PDF. This fall, the Biden administration announced billions more dollars to help make more tests available. Rapid COVID-19 Tests: When to Use Them and How They Work, COVID-19 Rapid Tests Now Available at Pharmacies: What to Know, How Antiviral Medications Fit in with Vaccinations in the Battle Against COVID-19, Is the COVID-19 Vaccine Linked to Tinnitus? In October, FDA issued a notice about Ellume's recall of its rapid antigen test, the first over-the-counter, fully at home COVID-19 kit to come to market in the U.S. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), People With Medicare Will Soon Be Able to Get Their 8 Free At-Home COVID Tests, Too. Thank you for taking the time to confirm your preferences. U.S. Food & Drug Administration. And if you're worried one of your at-home tests has been recalled, check the FDA's online list of recalls and its safety communications webpage. Our Picks for At-Home Fertility Tests to Track Your Reproductive Cycle. If everyone had a negative test, that would reduce the risk of introducing the virus into that circumstance. But he notes that following the instructions is important. Ellume This product has been 10/04/2021: Lab Alert: Ellume Issues Voluntary Recall of Specific A false positive may also cause someone to enter unnecessary isolation, lead to a delayed diagnosis of the actual cause of a persons illness or cause them to unnecessarily avoid vaccination under the false belief that they have already contracted the virus, even if they have not, the case relays. FDA labels Celltrion's latest recall of 310,000 COVID-19 tests as a Class I event By Nick Paul Taylor May 2, 2022 The recall stems from the fact that the emergency authorization of the Point of Care DiaTrust COVID-19 Ag Rapid Test only covers use by laboratories with CLIA certification. On Wednesday, November 10, the Food and Drug Administration (FDA) issued a recall of over two million Ellume at-home COVID-19 tests due to "higher-than-acceptable false positive test results," according to a statement on their website. "You should not assume that you had COVID-19 or have immunity to COVID-19. COVID-19 At-Home Test by SD Biosensor, Inc. CLINITEST Rapid COVID-19 Antigen Self-Test. Though no adverse health consequences or deaths came from the use of the tests, the FDA still urged people to dispose of the tests and ask for a refund. A false positive can also lead to unnecessary COVID-19 treatments, unnecessary isolation for the person and their close contacts, and the potential for COVID-19 to spread if people who are presumed positive are grouped together on the basis of an incorrect test result. One of the plaintiffs paid $65 for an Ellume test kit that she used in October to meet the requirements for returning to the U.S. from Ireland.