Z-2265-2025 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- June 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
Product Description
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
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 Pattern
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Code Information
Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;