Device product
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Z-2345-2025
Product summary
- Event
- Event 97319
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 237 units
- Official record key
device-enforcement:Z-2345-2025
Official wording
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.
Code information: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
Distribution pattern: Domestic: CA, FL, NC, NJ, NY;
Derived failure modes
-
Labeling or packaging
incorrectly labeled