Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELI
FDA device recall Z-2265-2025 · posted 2025-08-04 · Open, Classified
Recall details
- Recalling firm
- DRG International, Inc.
- 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).
- Action taken
- 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.
- Root cause
- Reprocessing Controls
- Status
- Open, Classified
- Product code
- CDX
- Quantity affected
- 47 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
- Date initiated
- 2025-06-04
- Date posted
- 2025-08-04
- Location
- Springfield, NJ
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