Dynex Technologies, Inc.: Device Recall
Recall #Z-2345-2025 · 07/16/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2345-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Dynex Technologies, Inc.
- Status
- Ongoing
- Date Initiated
- 07/16/2025
- Location
- Chantilly, VA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 units
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.
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.
Distribution Pattern
Domestic: CA, FL, NC, NJ, NY;
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.