FDAHealthJuly 16, 2025
Dynex Technologies, Inc. — Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
⚠️ 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.
Is this relevant to me?
- Geography
- CA, FL, NC, NJ, NY
- Source agency
- FDA
- Category
- Health
- Published
- July 16, 2025
Domestic: CA, FL, NC, NJ, NY;
What's affected?
- Product
- Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
- Lot code
- 863366
Additional details
Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 237 units.
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