Recalled COVID-19 Test Class Action Claims Ellume Has Not Provided Refunds

Ellume COVID-19 Recall Class Action Overview:

• Who: People who bought COVID-19 tests from Ellume USA LLC that were later recalled are suing the company.
• Why: The customers say they did not receive refunds for the recalled product.
• Where: The recall occurred nationwide.

Consumers who bought a recalled COVID-19 test that threw up false positives haven’t received refunds yet, a new class action lawsuit alleges.

Plaintiffs Karen Kerschen and Wallace Lovejoy filed the class action complaints against Ellume USA LLC Mar. 22 in a Maryland federal court, alleging violations of state and federal consumer laws. 

The plaintiffs say they are purchasers of Ellume’s Rapid Antigen At- Home COVID-19 Test Kits that Ellume recalled last year in two separate lots due to the potential for providing false positive test results. 

The plaintiffs say Ellume refused to refund purchasers of the recalled Ellume COVID Tests despite the tests being “inaccurate, unsafe and ineffective.”

According to the lawsuit, The Food and Drug Administration (FDA) identified the Ellume recall as a “Class I recall,” the most severe type of recall, because use of the Ellume COVID Tests risked “serious adverse health consequences or death.”

“Ellume’s actions and inactions injured consumers by causing them to pay for inaccurate, unsafe, ineffective, and worthless Ellume COVID Tests, and allowing it to retain the profits it derived from the sale of recalled products would unjustly enrich Ellume at the expense of the Class,” the class action lawsuit states. 

False Positive Ellume Test Affected Consumer’s Vacation

Kerschen says she purchased an Ellume test kit online for $65, including postage. She took the test ahead of a return flight to the United States from Ireland after a tour of the country. 

When she used the test, she got a positive result, forcing her whole group to quarantine immediately so that they missed scheduled, pre-paid activities. 

After realizing the test had been recalled for false positives, Kerschen took another test and realized she was negative. Despite her troubles, she has not been refunded for the test that delivered the false positive or any of the incidental costs she incurred from getting a positive test result, she says. 

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

The plaintiffs are suing for unjust enrichment and are seeking certification of the class action, damages, fees, costs and a jury trial.

Last year, more than 2.2 million at-home COVID-19 tests made by Ellume were recalled by the FDA. The tests were recalled because they have higher-than-acceptable false positive test results for COVID-19. 

If a test shows the person has the virus when they do not, it could delay diagnosing the actual cause of the person’s illness, which could be another life-threatening disease, the FDA warned.

What do you think of this recall? Let us know in the comments! 

The plaintiffs are represented by James P. Ulwick of Kramon & Graham, P.A.; Joseph G. Sauder and Lori G. Kier of Sauder Schelkopf LLC; and Daniel O. Herrera and Alexander J. Sweatman of Cafferty Clobes Meriwether & Sprengel LLP.

The Ellume USA COVID-19 Recall Class Action Lawsuit is Karen Kerschen et al., v. Ellume USA LLC, Case No. 1:22-cv-00704-RDB, in the U.S. District Court District of Maryland.

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