Chantilly, VA, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OPL | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus | Class II | Microbiology | 1 | 2023-09-29 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-16 | Class II | Ongoing | Z-2345-2025 | Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with th… | — | The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidenti… |
| 2020-07-05 | Class II | Ongoing | Z-1222-2022 | DYNEX Agility, Agility Analyzer, Model No. 67000 | — | Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control f… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-09-29 | K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit | OPL | Class II | Microbiology |