T4 Total ELISA kits have incorrect expiration date on labels and documentation
DRG International is recalling 47 units of T4 Total ELISA kits due to labeling errors. The box label and Certificate of Analysis incorrectly show an expiration date of March 31, 2026, but the actual shelf life of the reagents is January 31, 2026.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III medical device recall involving a labeling error (incorrect expiration date on packaging) with no reported illnesses or adverse events. Per the severity rubric, minor labeling errors on lower-risk device classes are classified as Moderate.
Plain-English summary
DRG International, Inc. is recalling 47 units of T4 Total ELISA kits (Model/Catalog Number EIA-4568, Lot 304K034) due to an expiration date labeling discrepancy.
The box label and Certificate of Analysis (CoA) state an expiration date of March 31, 2026. However, the actual shelf life of the standards and control solutions in the kit is January 31, 2026—two months earlier. The individual bottle labels within the kits are labeled correctly with the January 31, 2026 expiration date.
The kits have been distributed worldwide, including in the United States (California, Massachusetts, Pennsylvania) and internationally (Germany, Hong Kong, Moldova). Users relying on the box label or CoA for expiration information could potentially use reagents beyond their actual shelf life.
Users who have received this lot should disregard the expiration date shown on the box label and Certificate of Analysis. Use only the expiration dates shown on the individual bottle labels (January 31, 2026) to determine product usability.
The recalled product
- Product
- Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
- Manufacturer
- DRG International, Inc.
- Hazard
- incorrect-expiration-date
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: EIA-4568
- UDI-DI: 04048474045680
- Lot number: 304K034
Distribution
Distributed nationwide across the United States.
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