The lawsuit argues that "allowing Ellume to retain ill-gotten gains it derived from its sale of defective COVID-19 Home Tests" deprives the plaintiffs and "unjustly" enriches the company. How Can You Tell If a COVID Test Is Fake? Ellume said affected customers will be notified through the Three over-the-counter COVID-19 tests are now available at CVS, Walgreens, and Walmart pharmacies. Plaintiffs sue Ellume over 'ill-gotten gains' from recalled COVID-19 Home COVID Tests Being Recalled Due This recall has been identified by the FDA as a Class I recall, the most serious type of recall, as use of these tests may cause serious adverse health consequences or death. The FDA said false positives could lead to a delayed diagnosis or treatment of the actual cause of a persons illness; receiving unnecessary Covid-19 treatment which may have side effects; and disregard for precautions against Covid-19, including vaccination. Customers can check their products lot number against the FDAs database. Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. The FDA is recalling the test kits over serious concerns that users are receiving a positive test result when they do not have COVID. The tests can give people false Brisbane company Ellume recalls some COVID Contact the Recalling Firm's sales representatives for further instructions on the disposal of affected product. Ellume worked with the FDA to voluntarily remove the affected tests from the market. Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. The tests can give people false-positive results for the coronavirus. The initial recall covered around 400,000 tests that were found to have a higher than acceptable false positive rate because of a manufacturing issue. If you have one of the affected tests and go to use it, the app will let you know that the test has been recalled. Ellume Has Refused to Refund Buyers After Recalling Certain At 6. 10/04/2021: Lab Alert: Ellume Issues Voluntary Recall of Specific The tests were reportedly illegally imported into the US, which means they aren't FDA-authorized for emergency use. More than 2 million tests are now included in the recall, the US Food and Drug Administration said Wednesday. You can find out more about our use, change your default settings, and withdraw your consent at any time with effect for the future by visiting Cookies Settings, which can also be found in the footer of the site.