Z-2265-2025Class III

Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description...

Name: Z-2265-2025 Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description...
Creator: DRG International, Inc.
Published: 2025-06-04
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2025-06-04 / Open, Classified / root cause: labeling and UDI

FDA source

DRG International, Inc. began a recall of Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA on 2025-06-04. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2265-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-06-04
Posted: 2025-08-04
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
Product code: CDX Radioimmunoassay, Total Thyroxine
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).
Root cause tag: labeling and UDI
FDA 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 in commerce: 47 units
Distribution: Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Product codes and lots: Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2265-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-04

Product code CDX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)