Quidel is recalling the Lyra SARS-CoV-2 Assay (M120) due to a significant 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 some thermocyclers.
[pdf-embedder url=”https://dawamedical.com/wp-content/uploads/2021/07/Quidel-Recalls-Lyra-SARS-CoV-2-Assay-M120-Due-to-Risk-of-False-Negative-Results-_-FDA.pdf” title=”Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results _ FDA”]