Reported Aug 13, 2025 · Ongoing

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

DRG International, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DRG International, Inc. · 841 Mountain Ave · Springfield, NJ · 07081-3437

Is this the product you have?

  • Brand NameT4
  • Total ELISA Product NameT4
  • Total ELISA Model/Catalog NumberEIA-4568
  • Product DescriptionT4 Total ELISA
Lot codes and dates
  • Model/Catalog NumberEIA-4568
  • UDI-DI04048474045680
  • Lot number304K034
Amount recalled
47 units

Where it was sold

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).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.