Brand Name: T4 Total ELISA recallZ-2265-2025 · DRG International, Inc. · initiated Jun 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DRG International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Reprocessing Controls
What the company is doing
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.
Recall details
- Recall number
- Z-2265-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2025
- Posted by the FDA
- Aug 4, 2025
- Recalling firm
- DRG International, Inc.
- Quantity
- 47 units
- Product code
- CDX
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Product description
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Code information (models, lots, serial numbers)
Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- T-4 Total ELISA EIA-4568DRG Instruments Gesellschaft mit beschränkter Haftung · Radioimmunoassay, Total Thyroxine1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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