Class II

Medical Device Recall: Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

Dynex Technologies, Inc. · July 16, 2025

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

Domestic: CA, FL, NC, NJ, NY;

States Affected

CA, FL, NC, NJ, NY

Quantity Affected

237 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2345-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Dynex Technologies, Inc. Medical Device Recall: Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system. | SafeCheck