The emergence of different covid-19 variants and the corresponding surge in covid-19 cases brings with it an increased demand for covid-19 tests, particularly those that offer immediate results and can be done from the comfort of home. Unfortunately, like many other products on the market, at-home covid-19 tests are not immune to false claims or false results.

Earlier this month, the US Food and Drug Administration (FDA) announced a Class I recall of at-home covid-19 rapid antigen tests manufactured by E25Bio Inc. Just two weeks after the FDA announcement, E25Bio was hit with Urena v E25BIO Inc,(1) a consumer class action lawsuit claiming that the recalled tests are "worthless and inaccurate", illegally distributed and not FDA-approved. More specifically, the complaint alleged that E25Bio falsely labelled its tests and made a number of false claims, touting the "novel technology" with "better accuracy than 'gold standard' PCR [tests]". According to the complaint, the risks of false test results are dire, as a false negative can lead to further spread of covid-19, and a false positive may lead to a delay in the correct diagnosis and the appropriate treatment for a person's actual illness. Accordingly, the plaintiff, a New York resident, asserted warranty, fraud, consumer protection and unjust enrichment claims on behalf of a nationwide class and New York subclass of purchasers. He sought reimbursement of the cost of buying the E25Bio Tests, as well as statutory and punitive damages, and attorney fees and costs.

The ongoing pandemic means continued demand for quick and convenient tools to prevent and diagnose covid-19. This is not the first time the FDA has recalled an at-home covid-19 test,(2) and it is not likely to be the last. If recalls continue for these types of products, so too may class action lawsuits.

For further information on this topic please contact Rachel Raphael or Lily Hsu at Crowell & Moring LLP by telephone (+1 202 624 2500) or email ([email protected] or [email protected]). The Crowell & Moring LLP website can be accessed at


(1) 1:22-cv-01379 (SDNY) (filed 18 February 2022).

(2) Other recalls include:

  • Ellume COVID-19 Home Test;
  • Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test;
  • LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva); and
  • Flowflex COVID Rapid Tests.