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

FDA device recall Z-2345-2025 · posted 2025-08-22 · Open, Classified

Recall details

Recalling firm

Dynex Technologies, Inc.

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.

Action taken

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..*

Root cause

Labeling Change Control

Status

Open, Classified

Product code

LXG

Quantity affected

237 units

Distribution

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

Date initiated

2025-07-16

Date posted

2025-08-22

Location

Chantilly, VA