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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
80
510(k) clearances
Devices with this code
Simplexa™ Flu A/B & RSV Positive Control Pack — DIASORIN MOLECULAR LLCPanther Fusion® — Hologic, Inc.Alere™ i Influenza A & B — Alere Scarborough, Inc.Accula Flu A / B Test — MESA BIOTECH, INC.cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System — Roche Molecular Systems, Inc.Panther Fusion® — Hologic, Inc.PRODESSE — Hologic, Inc.Lyra — DIAGNOSTIC HYBRIDS, INC.PRODESSE — Hologic, Inc.Silaris Influenza A&B Control Kit — MESA BIOTECH, INC.BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel — BIOFIRE DIAGNOSTICS, LLCQIAstat-Dx® Respiratory Panel — QIAGEN GmbHRespiratory Pathogens Flex (RP Flex) Amplification Tray — LUMINEX CORPORATIONPanther Fusion® — Hologic, Inc.Xpert Flu — CEPHEIDFilmArray® Respiratory Panel (RP) — BIOFIRE DIAGNOSTICS, LLCAccula Flu A / B Control Kit — MESA BIOTECH, INC.ePlex System — GENMARK DIAGNOSTICS, INC.Xpert Xpress Flu/RSV — CEPHEIDRespiratory Pathogens Flex (RP Flex) Extraction Tray — LUMINEX CORPORATIONPanther Fusion® — Hologic, Inc.Respiratory Pathogens Flex (RP Flex) Amplification Tray — NANOSPHERE, INC.JBAIDS — BIOFIRE DEFENSE, LLCPanther Fusion® — Hologic, 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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