Dynex Technologies, Inc. recalls Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the…

Recall date

July 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2345-2025

FDA classification

Class II

Brand / firm

Dynex Technologies, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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