Class 2 Device Recall Agility

• Date Initiated by Firm: July 16, 2025
• Date Posted: August 22, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2345-2025
• Recall Event ID: 97319
• Product Classification: Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
• Product: Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
• Code Information: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366
• FEI Number: 1117676
• Recalling Firm/ Manufacturer: Dynex Technologies, Inc.; 14340 Sullyfield Cir; Chantilly VA 20151-1621
• For Additional Information Contact: Warren Robinson; 240-753-3081
• Manufacturer 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.
• FDA Determined Cause: Labeling Change Control
• Action: 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..*
• Quantity in Commerce: 237 units
• Distribution: Domestic: CA, FL, NC, NJ, NY
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.