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U.S. Department of Health and Human Services

Class 3 Device Recall T4 Total ELISA

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 Class 3 Device Recall T4 Total ELISAsee related information
Date Initiated by FirmJune 04, 2025
Date PostedAugust 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2265-2025
Recall Event ID 97196
Product Classification Radioimmunoassay, total thyroxine - Product Code CDX
ProductBrand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Code Information Model/Catalog Number: EIA-4568; UDI-DI: 04048474045680; Lot number: 304K034;
FEI Number 2245285
Recalling Firm/
Manufacturer		 DRG International, Inc.
841 Mountain Ave
Springfield NJ 07081-3437
For Additional Information ContactIna Hairston (US Agent for DRG Instruments)
US-973-5647555
Manufacturer 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).
FDA Determined
Cause 2		Reprocessing Controls
ActionOn 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.
Quantity in Commerce47 units
DistributionWorldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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