The test, which was granted emergency use authorization in March, uses a nasal swab to detect RNA from 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 said.
False negatives could also lead to further spread of the virus, putting others at risk.
Quidel said it has received five complaints about the test, but no reports of injury or death.
Read the FDA’s full news release here.
