Quidel recalls Lyra SARS-CoV-2 Assay

July 8, 2021

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.

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