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FDAJune 4, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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).

What to do

FDA enforcement status: Ongoing

Brands named

drg

UPCs

04048474045680

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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