FDA Medical devices recall ·
T4 Total ELISA Product Name: T4 Total ELISA Model recall
- Recall number
- Z-2265-2025
- Date
- (initiated June 4, 2025)
- Company / brand
- DRG International, Inc.
841 Mountain Ave, Springfield, NJ, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 47 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
Distribution
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
States: California Massachusetts Pennsylvania
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2265-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.