Class Action Alleges E25Bio Mislabeled Now-Recalled COVID-19 Tests

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A proposed class action has been filed against E25Bio, Inc. in the wake of a recall of the company’s “highly inaccurate” COVID-19 direct antigen rapid tests.

The 20-page complaint comes nearly three weeks after the FDA warned consumers not to use the E25Bio SARS-CoV-2 Antigen Test Kits due to the risk of false results. Per the suit, the FDA added that Cambridge, Massachusetts-based E25Bio, who voluntarily recalled its COVID-19 rapid tests on February 18, failed to provide the agency with adequate data demonstrating that the test’s performance was accurate. 

“Plaintiff and Class members were injured by the full purchase price of the Covid Tests because the Covid Tests are worthless and inaccurate, are not approved by the FDA, and have been illegally distributed,” the case alleges. 

The proposed class action contends that E25Bio’s recall is “deficient in numerous respects” given it does not promise consumers a refund and covers a relatively short time period, September 2020 to November 2021. The case argues that the ability for consumers to receive a refund through the recall was inadequately publicized, as it was stated only in a letter consumers could easily ignore or discard, and that the time period covered by the recall fails to account for E25Bio tests sold before or after that period that suffer from the same issues. 

Specifically, FDA guidelines dictate that at-home COVID-19 tests must reach 90 percent overall sensitivity, meaning they must be able to pick up nine out of every 10 positive tests identified via polymerase chain reaction (PCR) tests. According to the lawsuit, E25Bio’s tests “did not meet this standard.”

“On the contrary, in a comparative study of six at-home tests, five of the six tests ‘showed high specificity (> 98.0%),’ while the sixth test—Defendant’s Covid Tests—showed only 86.0% specificity,” the lawsuit states. “In other words, the Covid Tests failed to meet the FDA’s bar for accuracy and are significantly less accurate than other at-home COVID-19 tests.” 

Moreover, although E25Bio claimed that the COVID-19 tests at issue were “authorized” by the FDA, the agency has since made clear that they were not authorized, cleared or approved for distribution in the United States. 

No reasonable consumer would have bought an E25Bio COVID-19 rapid test had they known of the product’s inaccuracy or non-clearance by the FDA, the suit says. The lawsuit stresses that a false COVID-19 positive or negative can both injure consumers and potentially others whom they might be around. 

The lawsuit looks to cover all persons in the United States who bought one or more E25Bio COVID-19 direct antigen rapid tests.

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