SD Biosensor Facing Class Action After Voluntary Recall of Unapproved Standard Q At-Home COVID Tests

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The maker of the SDB Standard Q COVID-19 Ag Home Test faces a proposed class action that alleges the company has failed to disclose to the public that the tests are not authorized, cleared or approved for distribution in the United States by the Food & Drug Administration (FDA).

The 20-page lawsuit says that although defendant SD Biosensor USA, Inc. claims that its Standard Q at-home rapid COVID test can provide quick and accurate results, the product is nevertheless illegal to sell nationwide. The suit states that more than 397,000 Standard Q antigen tests were voluntarily recalled by SD Biosensor earlier this year due to confirmed reports that the products were illegally imported into the United States.

Further, the Standard Q COVID tests were the subject of a March 1, 2022 FDA advisory in which the agency warned consumers not to use the tests due to a risk of false results. 

The case says that although SD Biosensor stated at the time of its announcement that there was “no known distribution of these tests directly to consumers,” and that the decision to recall the products was made “out of an abundance of caution,” it is apparent that some consumers did, in fact, receive the COVID tests at issue.

“When Plaintiff and Class Members purchased Defendant’s Covid Tests, they, and [sic] had no reason to know, that Defendant’s Covid Tests were not authorized, cleared, or approved by the FDA for distribution or use in the United States (and thus illegally sold),” the complaint reads. “If Plaintiff and Class members had been aware that Defendant’s Covid Tests were illegally sold, not only would Plaintiff and Class Members not have purchased Defendant’s Covid Tests, they would not have even had the option to purchase them in the first place.” 

Moreover, the case says, no reasonable consumer would buy the Standard Q COVID tests had they known about the risk of false results. 

The lawsuit contends that SD Biosensor’s recall of the tests is “deficient” in that, for one, it promises no refund to consumers and instead advises buyers to simply discard and avoid using the test. Further, the recall was not adequately publicized, the plaintiff argues, highlighting that the defendant did not admit that some of the tests at issue were distributed to consumers until March 2022. 

“Plaintiff and Class members bargained for COVID-19 tests that were accurate, approved by the FDA, and were legally sold, and were deprived [of] the basis of their bargain when Defendant sold Covid Tests that did not match the aforementioned criteria,” the suit contends. 

The lawsuit looks to represent all consumers in the United States who purchased an SDB Standard Q COVID-19 Ag Home Test. 

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