FDA Device recall Z-2345-2025
Dynex Agility Sample Tips
- FDA Device
- Class II
- ongoing
- Published 2025-08-27
On 2025-08-27 the FDA classified a Class II recall of Dynex Agility Sample Tips by Dynex Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2345-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-16 |
| Published | 2025-08-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dynex Technologies |
| Distribution | CA, FL, NC, NJ, NY |
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
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.
Identifiers
| code_info | Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2345-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.