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If you are a clinical or public health laboratory professional. Note: If you need help accessing information in different file formats, see Return Acknowledgement Form to the Recalling Firm at productsafety@ellume.com 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? About 195,000are unused and can be replaced with new tests as part of the recall. Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. Rapid antigen tests can be useful to determine if you have an infection, but the timing and frequency could be key for accurate results. @US_FDA recall. Ellume Recalls 2.2 Million At-Home COVID Tests for False Positive "But it's also critical for others you interact with, because you can potentially infect them. Ellume The tests were reportedly labeled as authorized by the FDA though neither had been "authorized, cleared, or approved for distribution or use," the FDA said. The FDA reclassified the recall on Wednesday, stating that "use of these tests may cause serious adverse health consequences or death.". Customers can check thelot number on the test's carton and check whether it is among the recalled lots listed atwww.ellumecovidtest.com/return. Corrado Rizzi is the Senior Managing Editor of ClassAction.org. Can You Still Use a COVID-19 At-Home Test If Its Expired? Stay up to date with what you want to know. Four rapid antigen testssometimes known as at-home COVID-19 testshave been recently recalled by the FDA. COVID-19 At-Home Test by SD Biosensor, Inc. CLINITEST Rapid COVID-19 Antigen Self-Test. Ellume first Ellume first announced a voluntary recall of some of its rapid antigen tests in October due to an increased chance of false positives. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. People could disregard COVID-19 precautions due to the assumption that they've had COVID-19 or natural immunity from the virus. Negative tests results do not appear to be affected by the manufacturing issue. New research shows hospital mask mandates did little to slow the transmission of COVID-19 when Omicron was the dominant variant. tests deliver higher-than-anticipatedfalse positive results. The spokesperson added that the FDA did not indicate that the tests themselves caused harm, but rather the impact of the manufacturing error. Prior to Health, Grace was an associate editor at Insider where she spent the majority of her time trying to hack Google's algorithm. COVID Angela Underwood's extensive local, state, and federal healthcare and environmental news coverage includes 911 first-responder compensation policy to the Ciba-Geigy water contamination case in Toms River, NJ. The FDA issued a safety communication on October 6 alerting people of the potential of false-positive results from certain lots of the Ellume COVID-19 Home Test, due to manufacturing issues. More than 2 million Ellume Covid-19 home tests recalled due to The lawsuit alleges Ellume has refused to provide to test buyers the relief it implicitly agreed to provide when it voluntarily recalled the at-home COVID-19 tests. Recall of Ellume at-home COVID antigen tests grows to more than Home - ellume