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

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.

Details from the source

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; Quantity: 237 units Lot/code info: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;

UPC codes

5060456180072

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.