T4 Total ELISA (DRG International) – Expiration Date Mismatch (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Brand
DRG International, Inc.
Lot Codes / Batch Numbers
Model/Catalog Number: EIA-4568, UDI-DI: 04048474045680, Lot number: 304K034
Products Sold
Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
DRG International, Inc. is recalling Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Descr due to An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standard. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On June 4, 2025 FIELD SAFETY NOTICE letters were sent to customers. Action to be taken by distributors and end-users: Please check your inventory for the respective lot. Please use the CoA provided with this FSN. If you require corrected outer kit box label for your documentation, please contact DRG. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter. If you have any questions concerning this issue, please do not hesitate to contact us.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026