Dynex Technologies, Inc. recalls Dynex Agility Sample Tips

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.

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

On July 16, 2025, URGENT FIELD SAFETY NOTICE letters were emailed to customers. Action to Be Taken by the User: - Upon receipt, Quarantine affected devices and return or destroy them. - Customers have been provided a Field Safety Notice Customer Reply Form. Please complete this form, sign it and return to Dynex as soon as possible to acknowledge that you have received this information and have destroyed or returned to Dynex the impacted 67910 Agility Sample Tips Lot 863366. Transmission of this Field Safety Notice This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. (As appropriate) Please transfer this notice to other organisations on which this action has an impact. (As appropriate) Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback..*

• FDA enforcement recordOfficial FDA database entry for Z-2345-2025
• FDA device classification · LXGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Dynex Technologies, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.