BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2265-2025 · Initiated June 4, 2025

    Recall

    Recall Number
    Z-2265-2025
    Event Number
    97196
    Firm
    DRG International, Inc.
    FEI Number
    2245285
    Product Code
    CDX
    Status
    Open, Classified
    Root Cause
    Reprocessing Controls
    Initiated
    June 4, 2025
    Posted
    August 4, 2025
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437

    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).

    Action

    On June 4, 2025 FIELD SAFETY NOTICE letters were sent to customers. Action to be taken by distributors and end-users: Please check your inventory for the respective lot. Please use the CoA provided with this FSN. If you require corrected outer kit box label for your documentation, please contact DRG. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter. If you have any questions concerning this issue, please do not hesitate to contact us.

    Distribution

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

    Quantity

    47 units