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Dynex Technologies

2 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices

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

Class I - Dangerous

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.

Jul 16, 2025 Other Medical Devices View Details →

DYNEX Agility, Agility Analyzer, Model No. 67000

Class I - Dangerous

Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.

Jul 5, 2020 Other Medical Devices Nationwide View Details →