Influenza A And Influenza B Multiplex Nucleic Acid Assay
Microbiology · 21 CFR 866.3980
An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Recent MDR events
5 adverse event reports on file
- ID NOW INFLUENZA A/B 2.0 (24T)Mar 22, 2025MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2025-00119
- ID NOW INFLUENZA A/B 2.0 (24T)Mar 10, 2025InjuryAbbott Diagnostics Scarborough, Inc.1221359-2025-00087
- ID NOW INFLUENZA A/B 2.0 (24T)Mar 1, 2024MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2024-00233
- ACCULA FLU A / FLU B TESTFeb 13, 2023MalfunctionMesa Biotech3013022608-2023-00374
- SEKISUI DIAGNOSTICS SILARIS FLU PCRMay 10, 2019MalfunctionMesabiotech, Inc.MW5086579
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- Abbott Diagnostics Scarborough, Inc.Open, ClassifiedMar 13, 2026
Product Name: ID NOW" Influenza A & B 2
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1565-2026 · View FDA record ↗ - Abbott Diagnostics Scarborough, Inc.Open, ClassifiedApr 15, 2025
Brand Name: ID NOW Influenza A/B 2 24T
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1572-2025 · View FDA record ↗ - Abbott Diagnostics Scarborough, Inc.Open, ClassifiedApr 15, 2025
Brand Name: ID NOW Influenza A/B 2 24T
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1575-2025 · View FDA record ↗ - Centers For Disease Control and PreventionTerminatedJun 27, 2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
The H5b component may fail to amplify, resulting in an inconclusive result.
Z-2220-2024 · View FDA record ↗ - Luminex CorporationOpen, ClassifiedAug 15, 2019
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Z-2284-2019 · View FDA record ↗
Registered firms
29 firms currently registered for this product code
Acro Biotech Inc.
Montclair, CA, US
Applied Biocode, Inc.
Santa Fe Springs, CA, US
Enercon Technologies
GRAY, ME, US
Luminex Corporation
AUSTIN, TX, US
Ups Supply Chain Solutions, Inc.
Fairdale, KY, US
Abbott Diagnostics Scarborough, Inc.
Portland, ME, US
Biofire Diagnostics, Llc
Salt Lake City, UT, US
Genmark Diagnostics, Inc.
Carlsbad, CA, US
Centers For Disease Control And Prevention
ATLANTA, GA, US
Roche Molecular Systems, Inc.
PLEASANTON, CA, US
Autonomous Medical Devices Incorporated
Santa Ana, CA, US
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME, US
Hochuen Medical Sdn. Bhd.
SENAI Johor, MY
Hochuen Medical Technology Co.,ltd.
Shenzhen Guangdong, CN
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Luminex Corporation
Northbrook, IL, US
Diversified Synergies, Llc
Detroit, MI, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
510(k) clearances
20 clearances for this product code
- Centers for Disease Control and PreventionJul 11, 2025
K243274 · CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
- Centers for Disease Control and PreventionMar 14, 2025
K243931 · CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
- Centers for Disease Control and PreventionMay 21, 2024
K241110 · CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- Quidel CorporationMar 3, 2023
K230236 · Lyra Influenza A+B Assay
- Abbott Diagnostics Scarborough, Inc.Jun 24, 2022
K220801 · ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
- Centers for Disease Control and PreventionMar 10, 2020
K200370 · CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
- Indevr, Inc.Apr 22, 2019
K182513 · FluChip-8G Influenza A+B Assay
- Centers for Disease Control and PreventionMar 27, 2019
K190302 · CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit