# FDA recall Z-2265-2025

> **DRG International, Inc.** · Class III · device recall initiated 2025-06-04.

## Product

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).

## Distribution

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

## Key facts

- **Recall number:** Z-2265-2025
- **Recalling firm:** DRG International, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-04
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Springfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2025

## Citation

> AI Analytics. FDA recall Z-2265-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2265-2025. Source: US FDA. Licensed CC0.

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