Quidel Recalls Lyra COVID Diagnostic Test Due To Potential False Negative Results

  • Quidel Corporation QDEL is recalling its Lyra COVID-19 Assay test due to a high risk of false-negative results in patients with high amounts of the virus.
  • The FDA gave the molecular COVID-19 test emergency use authorization in March 2020. It uses a swab sample from the nasal area to detect RNA specific to the SARS-CoV-2 virus.
  • “False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death,” the FDA wrote on its website announcing the recall.
  • Quidel has received five complaints about the product, but there are currently no reports of injury or death from its use. 
  • The high amount of virus potentially causes PCR amplification to occur before a cycle‐threshold value of less than or equal to 5, the agency said, when the test is run on the following thermal cyclers: ThermoFisher QuantStudio 7 Pro, Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500, Bio-Rad CFX96 Touch, Roche LightCycler 480, and Qiagen RotorGene MDx.
  • Customers have been asked to run dilutions of clinical specimens generating Ct values of less than or equal to and reply to the firm.
  • The recall specifically covers Lyra SARS-CoV-2 tests manufactured over approximately one year, between March 17, 2020, and March 12, 2021, and distributed until May 27, 2021.
  • Price Action: QDEL shares are down 1.9% at $118.00 during the premarket session on the last check Thursday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCovid-19
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