Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. SCoV-2 Ag Detect Rapid Self-Test by InBios International, Inc. Our 8 Top Picks for At-Home HIV Tests to Help You Maintain Your Sexual Health, Test Your Fertility and Motility with these At-Home Sperm Tests, The 7 Best At-Home COVID-19 Tests of 2023, Tested and Reviewed, Get to the Bottom of Your Symptoms With an At-Home Bacterial Vaginosis Test, Luciras Over-the-Counter COVID-19 and Flu Test Receives FDA Authorization, You Can Test Positive for COVID-19 Long After Being Infected, FDA Now Recommends Taking Up to 3 At-Home COVID Tests to Confirm Negative Result, How to Avoid Buying a Fake At-Home COVID Test Online, How to Take An At-Home COVID-19 Test and What to Do If You Test Positive, FDA Authorizes First COVID-19 At-Home Test KitHere's What to Know, At-Home Fertility Tests to Help Guide Your Fertility Journey. 6. Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week. At-Home Flu Tests Are Surprisingly AccurateSo Why Don't We Have One Yet? The regulator At-home COVID test maker Ellume is recalling tests after customers received false positive results. The FDA is recalling the test kits over serious concerns that users are receiving a positive test result when they do not have COVID. 5. So far there have been 35 recorded false-positive tests sent to the FDA and no recorded deaths. The Tests manufactured February 24 to August 11 and distributed April 13 to August 26 are included in the recall. By initiating the recall, Ellume imposed upon itself an obligation to refund its customers for the purchase price they paid for the tests, whether used or unused, the suit contends. 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. Recommendations for Test Users and Caregivers. 2023 Healthline Media LLC. According to Ellume, the company has worked with the U.S. Food and Drug Administration ( FDA) to issue the voluntary recall and remove the affected at-home test kits from the market. Corrado Rizzi is the Senior Managing Editor of ClassAction.org. The tests can give people false-positive results for the coronavirus. See additional information. The information in this story is accurate as of press time. recalls U.S. Food & Drug Administration. Published They just detect the virus thats present, but if there is only a small amount of virus, it may not trigger a positive result. People could be overmedicated or unnecessarily treated for COVID-19. Ellume is notifying those affected by the recall, and those who try to use the affected tests will be told in the company's app that the test has been recalled and We have and will continue to work diligently to ensure test accuracy, in all cases," the spokesperson wrote. Thank you for taking the time to confirm your preferences. The communications informed customer that the Recalling Firm has received a number of complaints stating false positive test results for it COVID-19 Home Test kits. The form is complex, the company warned, as the FDA required Ellume to track and report data about the recall. Potential for false positive results with certain lots of Ellume COVID-19 home tests due to a manufacturing issue: FDA safety communication. 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. Learn more here. 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. Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results. Ellume last month recalled certain lots of its COVID-19 Home Test due to an increased chance of false-positive results. Ellume No-prescription, rapid COVID-19 home tests to be sold at CVS, Walgreens and Walmart beginning this week, Your California Privacy Rights/Privacy Policy. The company issued a voluntary recall of their at-home test on January 31, following reports that the test kits were illegally imported into the US, the FDA said. Read the full article You should continue to take recommended precautions, including vaccination, to avoid COVID-19 infection, following the Centers for Disease Control and Prevention's guidelines," according to the FDA. Ellume recalled specific lots of the test following the warning, according to a recall alert published by the FDA on November 16. Even after recalls, you may still come into contact with an unauthorized at-home COVID-19 test. Stay up to date with what you want to know. Healthline Media does not provide medical advice, diagnosis, or treatment. Thats also troublesome. Its available without a prescription and uses a nasal swab to detect if the coronavirus is present. 2023 Cable News Network. Ellume added more than 2 million tests to the recall the following month. On October 1, 2021, the digital diagnostics company Ellume announced a voluntary recall on specific lots of the Ellume COVID-19 Home Test, the companys More than 2 million tests made by the company that were distributed between April 13, 2021, and Aug. 26, 2021, are now targeted. Centers for Disease Control and Prevention. The agency says a false positive can be problematic, as it may lead to a delay in a correct diagnosis of the actual cause of a persons illness. Please share this message with your networks and invite them to opt in to LOCS to receive future updates. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English.