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Recall Observatory FDA recall evidence

Device product

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

Z-2345-2025

July 16, 2025

Class II

Product summary

Firm
Dynex Technologies, Inc.
Event
Event 97319
Status
Ongoing
Classification
Class II
Quantity
237 units
Official record key
device-enforcement:Z-2345-2025

Official wording

Reason: 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.

Code information: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled