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FDAJuly 16, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

dynex technologiesdynex

UPCs

5060456180072

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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