COVID-19 Test Class Action Claims E25Bio Sold Products That Were Inaccurate

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E25Bio COVID-19 Direct Antigen Rapid Tests Class Action Lawsuit Overview: 

• Who: Pedro Urena filed a class action lawsuit against E25Bio Inc. 
• Why: Urena claims E25Bio manufactured and sold direct antigen rapid COVID-19 tests that were inaccurate and falsely labeled as Federal Drug Administration approved.
• Where: The class action lawsuit was filed in New York federal court.

E25Bio Inc. manufactured, distributed and sold rapid COVID-19 tests that were inaccurate and falsely labeled as Federal Drug Administration (FDA) approved, a new class action lawsuit alleges. 

Plaintiff Pedro Urena claims the FDA has warned consumers not to use E25Bio’s COVID-19 Direct Antigen Rapid Test, which the company allegedly falsely asserts are “more accurate than PCR tests.” 

Urena wants to represent a nationwide class and New York subclass of consumers who purchased a COVID-19 test from E25Bio. 

The FDA warned consumers not to purchase COVID-19 tests manufactured and sold by E25Bio on Feb. 4 due to the risk of them producing false results. 

E25Bio had not provided the FDA with “adequate data” to demonstrate the accuracy of the test, the agency said. 

The FDA further advised physicians to retest any patients who had used a COVID-19 test sold by E25Bio. 

E25Bio Rapid COVID-19 Antigen Test Leads To False Positive

Urena says he tested positive for COVID-19 after taking a E25Bio rapid test that he believed was FDA approved and would be accurate based on its labels and disclosures. 

Following his positive test, Urena claims he went to a local clinic where a PCR test revealed he was negative for COVID-19. 

Urena claims he never would have purchased the rapid COVID-19 test from E25Bio had he known it was not accurate or approved, authorized and cleared by the FDA. 

“When Plaintiff purchased Defendant’s Covid Tests, Plaintiff did not know, and had no reason to know, that Defendant’s Covid Tests were not accurate, and were not authorized, cleared or approved by the FDA for distribution or use in the United States,” the class action lawsuit states. 

Urena claims E25Bio is guilty of fraud, unjust enrichment and breach of express warranty and in violation of New York General Business Law. 

Plaintiff is demanding a jury trial and requesting injunctive relief along with compensatory, statutory and punitive damages for himself and all class members. 

SD Biosensor, Inc. voluntarily recalled its at-home COVID-19 tests earlier this month after discovering they had been illegally imported into the United States. 

Have you purchased an E25Bio COVID-19 Direct Antigen Rapid Test? Let us know in the comments!

The plaintiff is represented by Joshua D. Arisohn, Max S. Roberts, Matthew A. Girardi and Julian C. Diamond of Bursor & Fisher, P.A. 

The E25Bio COVID-19 Direct Antigen Rapid Tests Class Action Lawsuit is Urena v. E25Bio Inc., Case No. 1:22-cv-01379, in the U.S. District Court for the Southern District of New York.

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