Z-2345-2025 Class II Ongoing
FDA device recall Z-2345-2025 was initiated by Dynex Technologies, Inc. on July 16, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 237 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2025
- Initiation Date
- July 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 units
Product Description
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.
Distribution Pattern
Domestic: CA, FL, NC, NJ, NY;
Code Information
Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;