BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2345-2025 · Reported August 27, 2025

    Enforcement

    Recall Number
    Z-2345-2025
    Event ID
    97319
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dynex Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 27, 2025
    Initiation Date
    July 16, 2025
    Classification Date
    August 21, 2025
    Address
    14340 Sullyfield Cir, N/A, Chantilly, VA, 20151-1621, United States

    Description

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

    Reason

    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.

    Code Info

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

    Distribution

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

    Quantity

    237 units