Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product...
FDA Recall #Z-2265-2025 — Class III — June 4, 2025
Product Description
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Reason for Recall
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).
Recalling Firm
DRG International, Inc. — Springfield, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
47 units
Distribution
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Code Information
Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated