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The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), are advising against the use of the LuSys Laboratories COVID-19 Antigen Test because they have not been cleared for use.
In total, nearly 165,000 at-home kits are subject to the recall, according to the FDA.
Officials said that the LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to detect proteins, called antigens for the virus.
The test then uses serum, plasma, or blood samples to look for antibodies produced by a person's immune system in response to SARS-CoV-2, the virus that causes COVID-19, suggesting recent or previous infection.
According to the FDA, LuSys Laboratories is recalling the tests because they have not been cleared for Emergency Use Authorization and therefore cannot be legally marketed or distributed in the US.
In addition, officials said that LuSys Laboratories did not provide appropriate validation data to show that the tests can perform accurately, which means there is a risk of a potential false positive, false negative, and subsequent misinterpretation of the results of the unapproved tests.
The FDA identified this as a Class I recall, which is the most serious type of recall, and use of the devices could cause serious injuries or death, though there have been no confirmed reports of adverse effects from consumers using the tests.
This recall expands on two others that were issued in January by the company.
“The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests,” according to the FDA. “Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.”
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