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

Recalled August 13, 2025 · FDA recall Z-2265-2025 · DRG International

Hazard
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). · FDA Class III
Units
47 units
Sold at
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.

Description

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).

Product
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Manufacturer(s)
DRG International, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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