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NxTAG® Respiratory Pathogen Panel v2
Luminex Molecular Diagnostics, Inc · Model I055C0465 · UDI-DI 00840487101872
QOF
Prescription
1
510(k) clearances
48
Adverse events
9
Recalls
31
Facilities
Description
The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.
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 inappropriate antibio |
| 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. The temperature e |
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