Device product
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Z-2265-2025
Product summary
- Event
- Event 97196
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 47 units
- Official record key
device-enforcement:Z-2265-2025
Official wording
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 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).
Code information: Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Derived failure modes
-
Unknown
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).