Ellume facing class action complaint over recalled COVID-19 at-home test kits

Image: FDA recall alert

A class action complaint was filed against Ellume USA LLC after the company recalled millions of at-home COVID-19 test kits last year. 

The complaint alleges Ellume is "unjustly retaining the monies that customers spent on the recalled test kits." 

"Ellume has failed to refund the money that Plaintiffs and the Class spent when they purchased the recalled Ellume COVID
Tests," the complaint states

Ellume issued two voluntary recalls of their at-home COVID-19 test kits in 2021, one in October and one in November, that together covered more than 2.2 million tests. The recalls were issued because the tests were found to have higher-than-acceptable false-positive test results for COVID, and were issued by the FDA as a class 1 recall. 

A false-positive test could lead to delayed diagnosis or treatment of what is actually ailing the tester; unnecessary COVID-19 treatment from a health care provider; and unnecessary isolation that could result in missing work or school, the FDA stated. 

The class action complaint includes two plaintiffs in addition to the class who received false positives. 

One tester in Indiana paid $65 for a test and received a false positive while she was traveling in Ireland, causing her and her entire tour group to quarantine unnecessarily and miss prepaid activities in October 2021. 

Another tester from Ohio bought two kits for $538 and had to cancel an upcoming trip unnecessarily due to a false positive, losing out on airfare money and prepaid activities in July 2021. 

The complaint alleges neither plaintiff has received a full refund yet from Ellume, despite having made contact with the company and learning their test kits were part of the recall. 

RELATED: 3 COVID-19 tests recalled after FDA warns about ‘high risk’ of false results

"In the case of Ellume’s recall of its COVID-19 Home Tests, a refund is the only viable remedy. Consumers purchase COVID-19 Home Tests for specific purposes—typically travel or to secure clearance to visit specific places or attend particular events—and, like Plaintiffs, have no use for a "replacement" test they no longer need to take," the complaint states. 

The lawsuit seeks to represent anyone who bought one of the recalled tests.

This story was reported from Detroit.