Springfield, NJ, United States
DRG International, Inc. recalls
7 recalls recorded since 2018, most recently on 2 July 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)6
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 July 2026
- Reason
- Potential for false negative patient results.
- Distribution
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0082-2027
- Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Ongoing Class III Medical devices
- Recall started
- 4 June 2025
- 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
- Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2265-2025
- Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Ongoing Class II Medical devices
- Recall started
- 7 October 2024
- Reason
- The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.
- Distribution
- Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0921-2025
- DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Ongoing Class III Medical devices
- Recall started
- 13 September 2024
- Reason
- The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
- Distribution
- AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0258-2025
- 17-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-1292
Ongoing Class III Medical devices
- Recall started
- 5 July 2024
- Reason
- Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
- Distribution
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2622-2024
- Product 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.
Terminated Class II Medical devices
- Recall started
- 21 December 2021
- Terminated
- 12 February 2024
- Reason
- ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
- Distribution
- NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0896-2022
- C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Ongoing Class II Medical devices
- Recall started
- 18 October 2021
- Reason
- Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
- Distribution
- Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0310-2022
- Total Thyroxine (T4) ELISA; REF EIA-1781
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.