DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total EL…

Recall date

June 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2265-2025

FDA classification

Class III

Brand / firm

DRG International, Inc.

Sold / distributed

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

Why it was recalled

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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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