Recall Z-2345-2025— Dynex Technologies, Inc.
Class II · Ongoing
Class II FDA medical device recall by Dynex Technologies, Inc., initiated 2025-07-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Dynex Technologies, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-16
- Firm location
- Chantilly, VA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.