DRG International, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2265-2025)

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:

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

Product Classification:

Class III

Date Initiated: June 4, 2025
Date Posted: August 13, 2025
Recall Number: Z-2265-2025
Event ID: 97196
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).

Status: Ongoing
Product Quantity: 47 units
Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated