The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. COVID-19 test kit maker Ellume is recalling some at-home tests after learning that they were reporting a higher-than-expected rate of false positive results indicating Rapid antigen tests can be useful to determine if you have an infection, but the timing and frequency could be key for accurate results. The agency warned that the use of these tests may cause serious adverse health consequences or death., There are ancillary risks from receiving a potentially false positive result that could cause harm, such as delaying diagnosis or treatment for the actual cause of a persons illness that is not COVID-19, an Ellume spokesperson wrote in an email to Verywell. The kitsdon't require aprescription and deliver results in minutes. -Customers/users that include customers that have used the products within 2 weeks and beyond 2 weeks. 1 min read. Visit www.ellumecovidtest.com/return for more instructions or call 1-888-807-1501 or email productsupport@ellume.com. 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. We havent used testing very much as an intervention in order to help us control COVID-19 here in the States, but theres increasing desire to do that both in private and public circumstances, he said. COVID You can review and change the way we collect information below. "Certain affected COVID-19 test kits were also supplied to the US Department of Defense to be further distributed to community health programs as part of the National Strategy for the COVID-19 Response and Pandemic Preparedness Plan," according to a press release sent to Health in October. Ellume acknowledged the false positive risk when it, about Ellume's recall of its rapid antigen test, the first over-the-counter, fully at home COVID-19 kit to. "Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.," a spokesperson told Insider in a statement. Recommendations for Test Users and Caregivers. Home COVID Tests Being Recalled Due Thank you, {{form.email}}, for signing up. Her additional health-related coverage includes death and dying, skin care, and autism spectrum disorder. ACON Laboratories issues a recall of non-EUA authorized Flowflex SARS-CoV-2 antigen rapid test (self-testing) tests from the U.S. market. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. About42,000 yieldedpositive results. What Does the Darkness of Your COVID Rapid Test Mean? U.S. Food & Drug Administration. Ellume added more than 2 million tests to the recall the following month. Ellume is now working with the FDA to remove the affected tests from the market, which were sent to retailers and distributors between April and August 2021. Bondi Partners. If your test kit has been recalled, do not use it, and complete a form on Ellume's website to receive a replacement. More than 2 million Ellume Covid-19 home tests recalled due to At-Home Flu Tests Are Surprisingly AccurateSo Why Don't We Have One Yet? When she returned to the U.S., the plaintiff asked Ellume to refund the cost of the recalled test. Ellume offered a "free replacement test" but the plaintiff requested a refund. If people did not receive a positive test from a different product at the same time, they should not assume that theyve had COVID-19 or natural immunity from the virus, the FDA said in a statement. The company has recalled 43 lotsshipped from April through August to retailers, distributors and the Department of Defense. Please share this message with your networks and invite them to opt in to LOCS to receive future updates. Do You Need to Retest After a Positive COVID-19 Result? Here's What Experts Say About Using At-Home Antigen Tests, How to Take An At-Home COVID-19 Test and What to Do If You Test Positive. Joe Hockey. Ellume said of the 3.5 million tests shipped to the US, an We have and will continue to work diligently to ensure test accuracy, in all cases," the spokesperson wrote. more than 2.2 million at-home rapid antigen COVID-19 test kits. Return Acknowledgement Form to the Recalling Firm at productsafety@ellume.com Since March 2020, the FDA has approved more than 400 tests for COVID-19 and sample collection devices. Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. Certain batches of the Ellume tests have a higher than acceptable false-positive rate, but the FDA says negative test results arent affected. When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies.

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