Dynex Technologies, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2345-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 16, 2025

Date Posted: August 27, 2025

Recall Number: Z-2345-2025

Event ID: 97319

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.

Status: Ongoing

Product Quantity: 237 units

Code Information:

Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated