Lower riskMedical device recall · FDA · Published June 4, 2025
T4 Total ELISA Kit: Incorrect Expiration Dates May Affect Test Accuracy
DRG International recalls T4 Total ELISA kits (model EIA-4568) due to incorrect expiration dates on box labels, which could lead to inaccurate test results. Affected kits were sold between 2025-01-01 and 2025-03-31.
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).
“T4 Total ELISA Kit: Incorrect Expiration Dates May Affect Test Accuracy.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52153-t4-total-elisa-kit-incorrect-expiration-dates-may-affect-test. Based on FDA recall #Z-2265-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2265-2025%22&limit=1).
The FDA announced on June 4, 2025, that DRG International, Inc. is recalling the T4 Total ELISA (Model EIA-4568) because expiration dates on kit box labels and Certificates of Analysis exceeded the shelf life of internal standards by two months. The agency classified this Class III recall as voluntary.
How to tell if you have it
Brand: DRG International
Product Name: T4 Total ELISA
Model/Catalog Number: EIA-4568
Lot number: 304K034
UDI-DI: 04048474045680
The hazard
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis exceeded the shelf life of the standards and control solutions in the kit by two months, showing 2026-03-31 instead of the correct 2026-01-31. The expiration dates on the bottle labels were correct.
Context
GovInfoNow's records show DRG International, Inc. has had five other recalls since October 18, 2021. Other recent recalls of similar products include the Cook Staged Extubation Set (March 5, 2026), the Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (May 13, 2026), and the Roche Elecsys Anti-TSHR Assay (November 21, 2025).
How to tell if you have this one
Check for the model number EIA-4568 on the kit box. Kits sold between January 2025 and March 2025 are affected. The box label shows an expiration date of March 31, 2026, but the actual shelf life ends January 31, 2026.
Brand
DRG International
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Expiration Dates
Verify the expiration date on the box label matches the actual shelf life of the test components (January 31, 2026).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Massachusetts, Pennsylvania.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2265-2025 (June 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2265-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.