BEUDAMED
    FDA Enforcement Class III Ongoing

    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

    Recall: Z-2265-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2265-2025
    Event ID
    97196
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DRG International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 13, 2025
    Initiation Date
    June 4, 2025
    Classification Date
    August 4, 2025
    Address
    841 Mountain Ave, N/A, Springfield, NJ, 07081-3437, United States

    Description

    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

    Reason

    An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).

    Code Info

    Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.

    Quantity

    47 units