SDB Recall of Unapproved At-Home Covid-19 Tests Class Action

Among the companies that have sought to sell at-home rapid tests for Covid-19 is SD Biosensor USA, Inc. (SDB). But the complaint for this class action alleges that these SDB Standard Q Covid-19 Ag Home Tests have not been approved by the Food and Drug Administration (FDA) and are therefore illegal to sell in the US.

The class for this action is all persons in the US who bought these Covid tests.

After more than two years of Covid-19, people have been looking for quick tests they can take at home, to avoid needing an appointment at a clinic or other medical facility and waiting for days for test results. The SDB Standard Q Covid-19 Ag Home Test promises on its front label to provide results within fifteen minutes.

The complaint quotes the company’s description of the test: a “rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.”

However, the complaint alleges that the tests were never “authorized, cleared, or approved by the FDA for distribution or use in the United States” and that they were “illegally imported into the U.S.”

SDB announced a voluntary recall of the tests on February 2, 2022 because of “confirmed reports” that the tests had been illegally imported. The complaint quotes the recall announcement as saying, “While there is no known distribution of these tests directly to consumers, SD Biosensor, Inc. is issuing this voluntary recall out of an abundance of caution.” However, the complaint claims that “it is apparent that some distribution to consumers occurred.”

On March 1, 2022, the FDA told consumers not to use the tests, the complaint says, and then, on March 16, it says, the FDA announced SDB’s recall of the tests, saying that, since the tests had not been approved by the FDA, “there is not sufficient data demonstrating that the test’s performance is accurate. This means there is a risk of both false-negative and false-positive test results.”

But the complaint alleges that the recall is inadequate in a number of ways.

First, it says, the recall did not include any provision for refunding to consumers the money they spent on the tests; it simply tells consumers to discard the tests and not use them.

Second, it claims the recall was not adequately publicized, noting that the FDA’s notification of the recall claimed that “there is no known distribution of these tests directly to consumers.”

Third, it claims that even reimbursing consumers for the cost of the tests is not enough, because in certain states, like New York, consumer protection laws entitle consumers to statutory damages above the purchase price in response to these kinds of recalls.

Article Type: Lawsuit
Topic: Medical Devices
Tags: Deceptive Advertising, Deceptive Labels, Not FDA Approved, Recall