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Respiratory Virus Panel Nucleic Acid Assay System
FDA product code OCC · Class 2 · Microbiology
84
Registered devices
808
Adverse events
25
Recalls
79
510(k) clearances
Devices with this code
Panther Fusion® — Hologic, Inc.ePlex System — GENMARK DIAGNOSTICS, INC.ARIES® Flu A/B & RSV Assay — LUMINEX CORPORATIONFILMARRAY — BIOFIRE DEFENSE, LLCLyra — QUIDEL CORPORATIONxTAG® RVP FAST (Respiratory Viral Panel Fast) — Luminex Molecular Diagnostics, IncXpert Flu+RSV Xpress — CEPHEIDAlere™ i Influenza A & B — Alere Scarborough, Inc.QIAstat-Dx® Respiratory Panel — QIAGEN GmbHPanther Fusion® — Hologic, Inc.ID NOW RSV — Alere Scarborough, Inc.xTAG® RVP (Respiratory Viral Panel) — Luminex Molecular Diagnostics, IncSilarisTM Influenza A&B Starter Pack — MESA BIOTECH, INC.Silaris RSV Supplemental Pack — MESA BIOTECH, INC.Xpert FLU/RSV XC — CEPHEIDRespiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge — NANOSPHERE, INC.ID NOW RSV Control Swab Kit — Alere Scarborough, Inc.Respiratory Virus Plus (RV+) Amplification Tray — NANOSPHERE, INC.ARGENE® ADENOVIRUS R-gene KIT US — BIOMERIEUX SAePlex System — GENMARK DIAGNOSTICS, INC.Simplexa™ Flu A/B & RSV Direct Gen II — DIASORIN MOLECULAR LLCRespiratory Virus Plus (RV+) Extraction Tray — NANOSPHERE, INC.Accula Programming Cassette — MESA BIOTECH, INC.Lyra — DIAGNOSTIC HYBRIDS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-30 | BioFire Diagnostics, LLC | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. |
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| 2024-09-05 | Luminex Molecular Diagnostics Inc | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, |
| 2024-08-07 | BioFire Diagnostics, LLC | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that m |
| 2023-01-30 | DiaSorin Molecular LLC | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error code |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
| 2020-10-30 | Luminex Corporation | Potential for a false-negative result. |
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