Health and Beauty

Quidel remembers Lyra Covid check on account of excessive danger of false adverse outcomes

A man inquires about a test for coronavirus disease (COVID-19) in a mobile test car in Brooklyn, New York, United States 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 was approved by 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. In after-hours trading, the company’s share slumped around 5%.

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