FDA Medical devices recall ·
Dynex Agility Sample Tips recall
- Recall number
- Z-2345-2025
- Date
- (initiated July 16, 2025)
- Company / brand
- Dynex Technologies, Inc.
14340 Sullyfield Cir, Chantilly, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 237 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
Distribution
Domestic: CA, FL, NC, NJ, NY;
States: California Florida North Carolina New Jersey New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2345-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.