Back in October and November, Ellume voluntarily recalled two separate lots of its Rapid Antigen At-Home COVID-19 Test Kits due to the risk of providing false positive results. The U.S. Food & Drug Administration classed the November recall as Class I, the most serious kind for the products’ potential to cause serious health consequences. Though Ellume said at the time that it had emailed consumers who used the kit instructing them to seek further testing to confirm their results, the company is now facing further fallout from the faulty kits in the form of a class-action lawsuit filed on March 22.
Two customers who used the defective kits filed the lawsuit on behalf of themselves and others affected by the recalled tests due to Ellume’s failure to provide refunds for the recalled tests, accusing the company of “unjustly” profiting off of “inaccurate, unsafe, ineffective, and worthless” products, states the class action complaint.
For one of the plaintiffs, the positive result she received from her faulty Ellume test kit while on vacation led to an unnecessary quarantine and added expenses for additional confirmation testing, which showed a negative result for COVID-19. After returning home, her request to Ellume for a refund for the cost of the test kit went unfulfilled.
For the second plaintiff, the faulty test kits led to the cancellation of a planned July 2021 vacation due to a false positive result for his wife, which resulted in additional costs when rebooking, as well as hundreds of dollars in additional testing to confirm results. After learning the result was a false positive, he tried to return the unused test kits for a refund, but Ellume refused. Later, in October 2021, the plaintiff got an email from Ellume informing him of the recall and offering a “free replacement test.” No longer needing the test kit, he and his wife contacted Ellume for a full refund of the original kits, which they were told they would receive. They later received a check from Ellume for less than the full cost of the test kits and related fees, with no explanation of the amount they were refunded.
The plaintiffs are seeking damages for the costs of the Ellume tests as well as attorneys’ fees and costs, statutory and punitive damages, and declaratory and injunctive relief, according to the complaint.
Get more details in the May 2022 issue of National Lab Reporter.