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. The company’s stock slumped around 5% in after-hours trading on Wednesday. Its shares rose just over 1% in Thursday afternoon trading.
“The FDA’s announcement is simply an aftermath 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 was said that none of its products were being recalled “in the general understanding of the term”.
“The FDA is merely making a public announcement of Quidel’s voluntary on-site corrective action letter, notifying our highly complex laboratory customers of a change in product labeling more than two months ago,” it says.
The FDA said the company is recalling its tests because the results for people with high levels of the SARS-CoV-2 virus may not be accurate when processed with the following thermal cyclers:
- ThermoFisher QuantStudio 7 Pro,
- Applied Biosystems 7500 Fast Dx,
- Applied Biosystems 7500,
- Bio-Rad CFX96 Touch,
- Roche LightCycler 480 or
- Qiagen RotorGene MDx