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Respiratory Virus Plus (RV+) Extraction Tray
NANOSPHERE, INC. · Model 20-009-020 · UDI-DI 00857573006232
OCC
Prescription
1
510(k) clearances
808
Adverse events (9 deaths)
25
Recalls
33
Facilities
Description
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
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, risk identified pred |
| 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 may lead modules and |
| 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 codes. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.