Quidel Recalls Lyra COVID Diagnostic Test Due To Potential False Negative Results

Quidel Corporation QDEL is recalling its Lyra COVID-19 Assay test due to a high risk of false-negative results in patients with high amounts of the virus.
The FDA gave the molecular COVID-19 test emergency use authorization in March 2020. It uses a swab sample from the nasal area to detect RNA 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.
Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use.
The high amount of virus potentially causes PCR amplification to occur before a cycle‐threshold value of less than or equal to 5, the agency said, when the test is run on the following thermal cyclers: ThermoFisher QuantStudio 7 Pro, Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500, Bio-Rad CFX96 Touch, Roche LightCycler 480, and Qiagen RotorGene MDx.
Customers have been asked to run dilutions of clinical specimens generating Ct values of less than or equal to and reply to the firm.
The recall specifically covers Lyra SARS-CoV-2 tests manufactured over approximately one year, between March 17, 2020, and March 12, 2021, and distributed until May 27, 2021.
Price Action: QDEL shares are down 1.9% at $118.00 during the premarket session on the last check Thursday.