Quidel Recalls Lyra SARS-CoV-2 Test Due to Potential False Negative Results

Original from Genomeweb

Quidel has issued a recall for certain lots of its Lyra brand SARS-CoV-2 tests due to the potential for false negative results in patient samples with relatively high amounts of virus. 

The US Food and Drug Administration identified this as a Class I recall — the most serious type — noting that this means use of the assay "may cause serious injuries or death."

The FDA said that Quidel is recalling the Lyra SARS-CoV-2 Assay "due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus." 

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.

The FDA said that false negative results "may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death," as well as further spread of the virus.

Quidel had received five complaints about the Lyra SARS-CoV-2 Assay, according to the FDA, but there have been no reports of injuries or death.

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.

The lot codes recalled are: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, 032820B, 040320, 040720, 040920, 041020, 174992, 175429, 175501, 175502, 175503, 176001, 176002, 176366, 176367, 176368, 178984, 178985, 180331, 180332, 180673, 180674, 180675, 182594, 184273, 185535, 185822, 186470, 186472, 187062, 187173, 187822, 189232, 189942, 190786, 193074, and 193977.

View source version on: https://www.genomeweb.com/pcr/quidel-recalls-lyra-sars-cov-2-test-due-potential-false-negative-results#.YObJyy21Fqs