COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA

COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA

Source : Medtech Insight

A recall of the Lyra SARS-CoV-2 Assay (M120) made by Quidel has been designated as high-risk class I by the US Food and Drug Administration.

The FDA said on 7 July that the real-time polymerase chain reaction (PCR) assay – used to qualitatively detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19 – could give results that aren’t correct.

The agency explained that there’s “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” these five types of thermocyclers:



Applied Biosystems 7500;


Applied Biosystems 7500 Fast Dx;


Bio-Rad CFX96 Touch;


Roche LightCycler 480; and


ThermoFisher QuantStudio 7 Pro.

A false-negative result could lead to a patient not being adequately cared for, as well as unchecked community spread of the virus. Further, “actions to limit exposure based on false-negative results might not be taken, such as isolating infected individuals,” the FDA said.

On 26 April Quidel recalled 18,385 Lyra assay kits, each of which contains supplies to test 86 individual samples. They were manufactured from March 2020 to March 2021, and distributed during the same time frame.

The company “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,” the FDA said.

Quidel sent a field corrective action email to customers on 26 April that gave a laundry list of things they should do if they have a recalled assay kit in their possession. That list can be found here.

By Shawn M. Schmitt