Dynex Agility Sample Tips — Class II medical device recall Z-2345-2025
Ongoing recall by Dynex Technologies, Inc., reported 2025-08-27, distributed in CA, FL, NC, NJ, NY. The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by
| Recall number | Z-2345-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dynex Technologies, Inc., Chantilly, VA, United States |
| Recall initiated | 2025-07-16 |
| Classified | 2025-08-21 |
| Reported by FDA | 2025-08-27 |
| Distributed | CA, FL, NC, NJ, NY |
| Quantity | 237 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05060456180072 |
| Lot numbers | 863366 |
| Model numbers | 67910 |
Product
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Reason for recall
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 misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2345-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.