Dynex Agility Sample Tips (Dynex) – Labeling Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Brand
Dynex Technologies, Inc.
Lot Codes / Batch Numbers
Model Number: 67910, UDI-DI: 5060456180072, Lot Number: 863366
Products Sold
Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
Dynex Technologies, Inc. is recalling Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consu due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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..*
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, NJ, NY, NC
Page updated: Jan 10, 2026