Dynex Technologies, Inc.
FDA Regulatory Profile
Dynex Technologies, Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2345-2025, Class II) was initiated on July 16, 2025. Its most recent 510(k) clearance was granted on September 29, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2345-2025 | Class II | Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/con | July 16, 2025 |
| Z-1222-2022 | Class II | DYNEX Agility, Agility Analyzer, Model No. 67000 | July 5, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit | September 29, 2023 |