Recall Register

DRG International, Inc.: FDA recalls

FDA enforcement reports name DRG International, Inc. as the recalling firm in 6 events. The events have 6 product records. The recalls started from 2021 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of DRG International, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
4 Jun 2025Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISADeviceClass III1Ongoing
7 Oct 2024DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361DeviceClass II1Ongoing
13 Sep 202417-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292DeviceClass III1Ongoing
5 Jul 2024Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.DeviceClass III1Ongoing
21 Dec 2021C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293DeviceClass II1Terminated
18 Oct 2021Total Thyroxine (T4) ELISA; REF EIA-1781DeviceClass II1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

DRG International, Inc.: events for each product type
TypeEvents
Device6
DRG International, Inc.: events in each class
ClassEvents
Class II3
Class III3
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of DRG International, Inc., by the year that the recall started. The largest year is 2024, with 3 events.

Official channels

Cite this page

Recall Register. DRG International, Inc.: FDA recalls. https://recallregister.com/firm/drg-international-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of DRG International, Inc. have?
Class II: 3 events. Class III: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of DRG International, Inc.?
FDA event 97196, which the firm started on 4 Jun 2025. The first product in the record is: Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
How many FDA recalls of DRG International, Inc. have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.