Quidel recalls Lyra Covid test due to high risk of false negative results

  • Quidel is recalling its Lyra SARS-CoV-2 Assay due to a high risk of false negative results.
  • "False negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death," the FDA wrote.
  • Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use.

Quidel is recalling its Lyra Covid-19 Assay test due to a high risk of false negative results in patients who actually have high amounts of the virus.

Quidel is a company that produces diagnostic healthcare products around the world. The Covid test was given emergency use authorization by the Food and Drug Administration in March. It uses a swab sample from nasal area to detect RNA that is specific for the SARS-CoV-2 virus.

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"False negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death," the FDA wrote on its website announcing the recall.

False negative results could also lead to further spread of the virus in a community and puts other high-risk individuals at 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 shares slumped by about 5% in afterhours trading.

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