PlainRecordsBrand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description…
- 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…
- Status
- Ongoing
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
- Enforcement report date
- Aug. 13, 2025
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- DRG International, Inc.
- Product
- Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
- 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).
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
- Quantity
- 47 units
- Codes and lots
- Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
- Recall started
- June 4, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Radioimmunoassay, Total Thyroxine
- Root cause (FDA)
- Reprocessing Controls
- What the company told customers
- On June 4, 2025 FIELD SAFETY NOTICE letters were sent to customers. Action to be taken by distributors and end-users: Please check your inventory for the respective lot. Please use the CoA provided with this FSN. If you require corrected outer kit box label for your documentation, please contact DRG. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter. If you have any questions concerning this issue, please do not hesitate to contact us.
- Recall number
- Z-2265-2025
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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).”Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA, FDA enforcement report, 2025-08-13. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: Radioimmunoassay, Total Thyroxine
Distributed in (FDA's record): California Massachusetts Pennsylvania and nationwide
This recall among the others
- FDA's enforcement report came 70 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- DRG International: 3 other recalls or notices on this site in the three years before this one (from Aug. 14, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-2265-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2265-2025, Aug. 13, 2025. "Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description." PlainRecords, https://plainrecords.com/recall/device/z-2265-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections