FDA Medical Device Recalls (openFDA)
DRG International, Inc.: Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
- Recall number
- Z-2265-2025
- Recalling firm
- DRG International, Inc.
- Product
- Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
- Status
- Open, Classified
- Initiated
- 2025-06-04
- Posted
- 2025-08-04
- Terminated
- not on file
- 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).
- Root cause
- Reprocessing Controls
- Action
- 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.
- Quantity
- 47 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
- Lot, serial or model codes
- Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CDX
- Firm FEI
- 2245285
- Firm city
- Springfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28