Ellume recalled tests
WebNov 11, 2024 · The U.S. Food and Drug Administration has announced a recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume. The federal regulatory … WebDec 22, 2024 · As of Dec. 16, the FDA lists this as the only active recall for COVID-19 home tests. Earlier this year, Ellume test kits were voluntarily recalled by the manufacturer …
Ellume recalled tests
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WebOct 6, 2024 · Ellume recalls 200,000 Covid-19 test kits over false positives. Australian medtech Ellume has recalled nearly 200,000 Covid-19 test kits in the US due to … WebNov 16, 2024 · The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue ...
WebNov 11, 2024 · Updated on: November 11, 2024 / 7:12 PM / MoneyWatch. The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests … WebThe recalled tests were Ellume’s At-Home Rapid Antigen Covid-19 Test Kits, made between February 24, 2024 and August 11, 2024 and distributed between April 13, 2024 …
WebApr 13, 2024 · The court action comes after Ellume, which inked a $300 million deal with the US government in 2024, was forced to recall 2.2 million test kits last year over concerns about higher than acceptable ... WebNov 13, 2024 · The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume, the first company to get FDA approval for over-the-counter COVID tests, due to “higher-than-acceptable false-positive test results.”. The recall is an expansion of last month’s recall of 200,000 kits for the same issue.
WebMar 23, 2024 · 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. …
WebThe Ellume COVID-19 Home Test from Ellume Health (Brisbane, Aus) became the first COVID-19 diagnostic authorized for home use by the United States FDA in December 2024. ... Ellume overcame critical technology challenges during the development of their influenza test. In addition, it faced a recall of its COVID-19 home test in 2024 due to false ... novatech ashland ohWebNov 15, 2024 · The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. More than 2 million tests … how to soften sculpeyWebOct 6, 2024 · Brisbane-based Ellume developed the test and earlier this year signed a $300 million deal with the US to supply the rapid at-home antigen tests. It received US Food … novatech authenticatorWebNov 11, 2024 · Ellume first announced a voluntary recall of some of its rapid antigen tests in October due to an increased chance of false positives. More than 2 million tests are now included in the recall, the ... how to soften scratchy clothesWebOct 5, 2024 · Questions about the recall can be directed to the Ellume Product Support Team at 1-888-807-1501, Monday through Friday, from 9 a.m. to 5 p.m. ET, to arrange a replacement test kit. novatech analytical solutions incWebOct 5, 2024 · Tests from the specific lots are now being recalled. If you have an impacted Ellume COVID-19 Home Tests – you can see the list of affected lot numbers below – you can request a replacement here. Affected home tests were distributed to retailers and distributors from April through August 2024. how to soften scratchy wool yarnWebJan 26, 2024 · Recalled Test Kits. Recently, the FDA recalled 200,000 boxes of the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which is made by ACON Laboratories. The test does not have an emergency use authorization (EUA) from the FDA. The recalled test is in a blue box while the approved version is in a white box. novatech animal health