Medical Device Recall: Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
DRG International, Inc. · June 4, 2025
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
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
States Affected
NATIONWIDE
Quantity Affected
47 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2265-2025
Status: ongoing
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