The Food and Drug Administration (FDA) published a recall this week from manufacturer of diagnostic healthcare products, Quidel Corporation.
According to the recall notice, the company is recalling
the Lyra SARS-CoV-2 Assay (M120) 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 when using the following thermocyclers:
- ThermoFisher QuantStudio 7 Pro,
- Applied Biosystems 7500 Fast Dx,
- Applied Biosystems 7500,
- Bio-Rad CFX96 Touch,
- Roche LightCycler 480, or
- Qiagen RotorGene MDx
False negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death. False negative results can also lead to further spread of the SARS-CoV-2 virus, when presumed negative patients are introduced into groups within health care, long-term care, or other similar facilities. Actions to limit exposure based on false negative results might not be taken, such as isolating infected individuals.
Quidel 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 Lyra SARS-CoV-2 Assay (M120) is a real-time polymerase chain reaction (RT-PCR) assay used to qualitatively detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The test uses nasal, nasopharyngeal (NP), or oropharyngeal (OP) swab samples from patients suspected by their healthcare provider of illness caused by the COVID-19 virus.
Specifics of the recalled product:
- Lyra SARS-CoV-2 Assay (M120)
- Lot codes: 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, 193977
- Manufacturing Dates: March 17, 2020 to March 12, 2021
- Distribution Dates: March 17, 2020 to May 27, 2021
- Devices Recalled in the U.S.: 18385 (each kit contains 96 reactions)
- Date Initiated by Firm: April 26, 2021
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