Toronto, CA · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Class II | Microbiology | 1 | 2024-10-02 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | 1 | 2024-03-11 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-09-05 | Class II | Ongoing | Z-0043-2025 | NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 | — | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, … |
| 2024-09-05 | Class II | Ongoing | Z-0042-2025 | NxTAG Respiratory Pathogen Panel, REF: I051C0447 | — | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, … |