A man inquires about a test for coronavirus disease (COVID-19) in a mobile test car in Brooklyn, New York on June 2, 2021.
Brendan McDermid | Reuters
Quidel is recalling its Lyra Covid-19 assay test due to a high risk of false negative results in patients who actually have high levels of the virus.
Quidel is a company that makes diagnostic health products worldwide. The Covid test received emergency approval from the Food and Drug Administration in March. It uses a swab sample from the nasal area to detect RNA that is specific for the SARS-CoV-2 virus.
“False-negative results can lead to delayed diagnosis or inadequate treatment of SARS-CoV-2, which can harm the patient, cause serious illness and death,” the FDA wrote on its website announcing the recall.
False negative results could also spread the virus further into a community, putting others at high risk of injury or death.
Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use. The company’s stock plunged around 5% in after-hours trading.