Quidel is recalling the Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results, according to the U.S. Food and Drug Administration (FDA).
The RT-PRC test uses nasal, nasopharyngeal (NP), or oropharyngeal (OP) swab samples from patients suspected by their healthcare provider of illness caused by the COVID-19 virus.
The FDA, which identified this as a Class I recall, said there is a risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus potentially causing the PCR amplification to occur before a cycle‐threshold (Ct) value ≤5 when using the following thermocyclers:
· ThermoFisher QuantStudio 7 Pro
· Applied Biosystems 7500 Fast Dx
· Applied Biosystems 7500
· Bio-Rad CFX96 Touch
· Roche LightCycler 480
· Qiagen RotorGene MDx
The FDA said Quidel has received five complaints about the Lyra SARS-CoV-2 Assay (M120); however, there have been no reports of injuries or death from this issue.
