Home › Device types › OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
FDA product code OZE · Class 2 · Microbiology
28
Registered devices
5
Adverse events
5
Recalls
21
510(k) clearances
Devices with this code
Alere™ i Influenza A & B — Alere Scarborough, Inc.Silaris Dock — MESA BIOTECH, INC.BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel — BIOFIRE DIAGNOSTICS, LLCRespiratory Pathogens Flex (RP Flex) Amplification Tray — LUMINEX CORPORATIONePlex System — GENMARK DIAGNOSTICS, INC.Respiratory Pathogens Flex (RP Flex) Extraction Tray — LUMINEX CORPORATIONRespiratory Pathogens Flex (RP Flex) Amplification Tray — NANOSPHERE, INC.BioCode Respiratory Pathogen Panel — APPLIED BIOCODE, INC.Respiratory Pathogens Flex (RP Flex) Extraction Tray — NANOSPHERE, INC.ePlex System — GENMARK DIAGNOSTICS, INC.Accula Programming Cassette — MESA BIOTECH, INC.ePlex System — GENMARK DIAGNOSTICS, INC.Alere i Influenza A & B 2 — Alere Scarborough, Inc.Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONRespiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge — NANOSPHERE, INC.BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini — BIOFIRE DIAGNOSTICS, LLCID NOW Influenza A & B 2 Control Swab Kit — Alere Scarborough, Inc.ID NOW Influenza A & B Control Swab Kit — Alere Scarborough, Inc.BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel — BIOFIRE DIAGNOSTICS, LLCAlere™ i Influenza A & B Control Swab Kit — Alere Scarborough, Inc.Accula Dock — MESA BIOTECH, INC.Lyra — DIAGNOSTIC HYBRIDS, INC.SilarisTM Influenza A&B Starter Pack — MESA BIOTECH, INC.BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini — BIOFIRE DIAGNOSTICS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-09 | Abbott Diagnostics Scarborough, Inc. | It was confirmed that the impacted lot has 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. |
| 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. |
| 2024-04-26 | Centers For Disease Control and Prevention | The H5b component may fail to amplify, resulting in an inconclusive result. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, re |
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