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Recall Observatory FDA recall evidence

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

June 04, 2025

Class III

Product summary

Firm
DRG International, Inc.
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

    reason.no_named_rule · v1.0.0

    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).