FDA-Device2025-08-13Class III
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
DRG International, Inc.
Hazard
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).
Sold states
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Affected count
47 units
Manufactured in
841 Mountain Ave, N/A, Springfield, NJ, United States
Products
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2025Don't want to check this manually?
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