This story has been updated to include comments from Quidel.
NEW YORK - 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."
On its website, 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 5 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.
In a statement, Quidel emphasized that the FDA announcement "is simply an after-action report and has nothing to do with the performance or quality" of the Lyra SARS-CoV-2 assays.
Futhermore, the Lyra products are not being recalled in the common understanding of the term, the firm said.
Rather, the FDA is providing public notice of Quidel’s voluntary field corrective action letter alerting high-complexity laboratory customers of a product labeling change that occurred in April, Quidel said.
"While any field labeling change or field communications action can be designated a Class I recall under standard FDA guidelines, our Lyra SARS-CoV-2 Assay has always performed per specifications," the firm said. "Our expert laboratory customers at high-complexity labs simply substituted the new labeling in processing the Lyra tests," Quidel added.
In collaboration with the FDA, the firm noted that its team team "confirmed the rare potential for patients with high SARS‐CoV‐2 viral loads to be falsely interpreted as negative" if target amplification occurs prior to a cycle‐threshold value of 5.
"Quidel worked with the FDA and generated a solution to the issue," the firm said, noting that all of the field notifications were carried out in May.