Recall Z-2265-2025— DRG International, Inc.
Class III · Ongoing
Class III FDA medical device recall by DRG International, Inc., initiated 2025-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA. Reason: 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)..
- Recalling firm
- DRG International, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-06-04
- Firm location
- Springfield, NJ, United States
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.