T4 Total ELISA kit box expiry exceeds the standards' shelf life
T4 Total ELISA kits are being recalled because the expiration date on the kit box label and Certificate of Analysis exceeded the shelf life of the standards and control solutions by two months. 47 units affected.
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: FDA Class III recall over an incorrect expiry date on the outer box and certificate, with the bottle labels themselves correct.
Plain-English summary
The T4 Total ELISA, model/catalog number EIA-4568, UDI-DI 04048474045680, is being recalled. The action covers 47 units from lot 304K034.
According to the notice, 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 2026-01-31. The expiration dates on the bottle labels were correct at 2026-01-31. The FDA classified the action as Class III, its least serious classification.
Distribution was worldwide, including nationwide in the United States in California, Massachusetts and Pennsylvania, and to other countries.
Laboratories should identify affected stock using the catalog number, UDI-DI and lot number above and follow the instructions issued by the manufacturer.
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.
- Affected units
- 47
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
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