Ellume Covid Rapid Home Tests Recalled with No Refunds Class Action

Covid tests that provide prompt results at home have become important to people as the pandemic drags on. This class action brings suit against Ellume USA, LLC because it did not refund customers’ money when it recalled certain lots of its Rapid Antigen At-Home Covid-19 Test Kits. According to the complaint, the kits were recalled because they were inaccurate and producing false positives.

The Nationwide Class is all persons in the US who bought Ellume Covid Tests that were included in Ellume’s October 1 and November 10, 2021 recalls. In the alternative, the complaint proposes and Indiana Class and an Ohio Class, for persons in those respective states who bought the tests subject to the recalls.

Ellume is a biotech company and a maker of diagnostic tests. It developed a test, the complaint alleges, that “it claimed would produce quick and accurate results from the convenience of the purchaser’s home or while traveling.” According to the complaint, the Ellume tests “were designed to produce a test result within fifteen minutes by detecting proteins from the SARS-CoV-2 virus collected from a nasal sample.” They were available without prescription to persons who were more than two years old.

The complaint quotes Ellume as touting the accuracy of the test, saying, “The Ellume Covid-19 Home Test demonstrated 96% accuracy in clinical studies. Our test is the only OTC antigen home test to: Give you accurate results in a single test, in 15 minutes…”

False positives are a problem, the complaint alleges, not just because the information is wrong: False positives for Covid-19 “can lead to an individual receiving unnecessary treatment from health care providers … which can result in side effects. False positive test results can also threaten individuals with unnecessary isolation, including monitoring households or close contacts for symptoms, limiting contact with family or friends, and missing school or work…” Also, they may delay treatment for the actual cause of an illness or they may lose money via cancelled travel plans or events.

“On or about October 1, 2021,” the complaint alleges, “Ellume issued a voluntary recall of approximately 427,994 Ellume Covid Tests and explained it had done so because certain lots were found to product higher than acceptable false positive results due to a manufacturing issue.” It issued a second voluntary recall of other lots on or around November 10, 2021, putting the number of recalled tests at more than two million units.

The Food and Drug Administration (FDA) categorized it as a Class I recall, a serious classification of recall involving “serious adverse health consequences or death.”

The recalled tests were Ellume’s At-Home Rapid Antigen Covid-19 Test Kits, made between February 24, 2021 and August 11, 2021 and distributed between April 13, 2021 and August 26, 2021.

However, the complaint claims that Ellume has not reimbursed consumers for what it calls “inaccurate, unsafe, ineffective, and worthless Ellume Covid Tests” and instead has kept the profits it earned by selling them.

Article Type: Lawsuit
Topic: Consumer
Tags: Deceptive Advertising, Deceptive Labels, Unjust Enrichment