Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total
Summary
The FDA issued a Class III for Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: by DRG International, Inc.. 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 standard.
Details
Source
Device Recall
External ID
Z-2265-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Lot/Code Info: Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
Quantity Affected: 47 units
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).
Distribution
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-04
Company
Springfield, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DRG International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DRG International, Inc. have FDA actions?
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2265-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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