Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog… — Class III medical device recall Z-2265-2025
Ongoing recall by DRG International, Inc., reported 2025-08-13, distributed nationwide. An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA)
| Recall number | Z-2265-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG International, Inc., Springfield, NJ, United States |
| Recall initiated | 2025-06-04 |
| Classified | 2025-08-04 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, HK |
| Quantity | 47 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04048474045680 |
| Lot numbers | 304K034 |
| Model numbers | EIA-4568 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2265-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.