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 health-care 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 the nasal area to detect RNA that is specific to the SARS-CoV-2 virus.
"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 may put 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 after-hours trading on Wednesday. It's shares were up by just over 1% in midday trading Thursday.
"The FDA announcement is simply an after-action report and has nothing to do with the performance or quality of our Lyra SARS-CoV-2 Assays," Quidel said in a statement sent to CNBC on Thursday. It said none of its products were being recalled "in the common understanding of the term."
"The FDA is simply providing public notice of Quidel's voluntary field corrective action letter alerting our high-complexity laboratory customers of a product labeling change over two months ago," it said.
The FDA said the company was recalling its tests because the results may not be accurate for people with high amounts of the SARS-CoV-2 virus if processed with the following thermocyclers:
- ThermoFisher QuantStudio 7 Pro,
- Applied Biosystems 7500 Fast Dx,
- Applied Biosystems 7500,
- Bio-Rad CFX96 Touch,
- Roche LightCycler 480, or
- Qiagen RotorGene MDx