Quidel recalls Lyra SARS-CoV-2 assay due to false-negative tests

By LabPulse.com staff writers

July 7, 2021 -- Quidel is recalling its Lyra SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) assay for detecting infection with SARS-CoV-2 due to false-negative results, according to the U.S. Food and Drug Administration (FDA).

In a July 7 announcement, the FDA said that Quidel began the recall on April 26. The recall affects over 18,000 kits, with each kit containing 96 reactions.

The FDA said that Quidel initiated the recall after receiving five complaints about the assay, but the agency noted that there have been no reported cases of injuries or deaths from use of the test. The FDA classified the move as a class I recall, the agency's most serious type of recall.

The agency said that Quidel was recalling the test "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."

The issue occurs when using thermocyclers from the following manufacturers:

  • QuantStudio 7 Pro from ThermoFisher
  • 7500 and 7500 Fast Dx from Applied Biosystems
  • CFX96 Touch from Bio-Rad Laboratories
  • LightCycler 480 from Roche
  • RotorGene MDx from Qiagen

Quidel received an emergency use authorization from the FDA for Lyra in March 2020.

Additional information on the recall is available on the FDA's website.

Quidel secures EUA for rapid antigen test
Quidel has garnered an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its Sofia Q rapid antigen test, the latest addition...
Quidel secures Health Canada approval for Sofia SARS-CoV-2 test
Health Canada has approved Quidel's Sofia antigen test for the detection of coronavirus infection in both symptomatic and asymptomatic people.
Boom in COVID testing drives Quidel's Q1 financials
Quidel on April 22 announced preliminary numbers for the first quarter of 2021 that saw revenue from the company's line of COVID-19 tests boom to $280 million...
Quidel nabs EUA from FDA for SARS-CoV-2 antigen test
Quidel has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QuickVue point-of-care assay that detects...
Quidel gets EUA for combo flu, COVID-19 test
Quidel has received a U.S. Food and Drug Administration emergency use authorization (EUA) for a rapid diagnostic that can simultaneously identify influenza...

Copyright © 2021 LabPulse.com

Last Updated ls 7/7/2021 3:36:27 PM

Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current