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Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
FDA product code QOF · Class 2 · Microbiology
46
Registered devices
48
Adverse events
9
Recalls
33
510(k) clearances
Devices with this code
QIAstat-Dx® Respiratory Panel Plus — QIAGEN GmbHAlinity m — ABBOTT MOLECULAR INC.LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab Kit — DIASORIN MOLECULAR LLCcobas liat SARS-CoV-2, Influenza A/B & RSV control kit — Roche Molecular Systems, Inc.Panther Fusion® — Hologic, Inc.BioFire® Respiratory Panel 2.1 — BIOFIRE DIAGNOSTICS, LLCTaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES CORPORATIONAlinity m — ABBOTT MOLECULAR INC.Panther Fusion® — Hologic, Inc.NxTAG® Respiratory Pathogen Panel v2 — Luminex Molecular Diagnostics, IncBD Respiratory Viral Panel for BD MAX™ System — BECTON, DICKINSON AND COMPANYAlinity m — ABBOTT MOLECULAR INC.Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack — DIASORIN MOLECULAR LLCBIOFIRE ® SPOTFIRE ® Respiratory (R) Panel — BIOFIRE DIAGNOSTICS, LLCBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel — BIOFIRE DIAGNOSTICS, LLCBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini — BIOFIRE DIAGNOSTICS, LLCQIAstat-Dx® Respiratory Panel Plus — QIAGEN GmbHRESPDIRECT™ — Hologic, Inc.cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test — Roche Molecular Systems, Inc.cobas® Respiratory 4-flex — Roche Molecular Systems, Inc.cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test — Roche Molecular Systems, Inc.Visby Medical Respiratory Health — Visby Medical, Inc.TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control — LIFE TECHNOLOGIES CORPORATIONPanther Fusion® — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | BioFire Diagnostics, LLC | Due to increase in false negative results |
| 2026-04-01 | BioFire Diagnostics, LLC | Respiratory/sore throat panel test may result in false negative results and control failures. |
| 2025-10-22 | BioFire Diagnostics, LLC | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. |
| 2025-06-25 | Nuclein LLC | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) |
| 2025-03-12 | Qiagen Sciences LLC | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. |
| 2024-11-08 | Hologic, Inc. | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| 2023-11-27 | BioFire Diagnostics, LLC | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to i |
| 2023-05-08 | BioFire Diagnostics, LLC | Due to manufacturing issue, panels may result in false negative results. |
| 2023-02-01 | BioFire Diagnostics, LLC | Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance |
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