DRG recalls
7 official recalls and safety alerts involving DRG since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with DRG or the relevant agency.
- 2026-10-14
USDRG International, Inc. recalls Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Potential for false negative patient results.
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice →- 2025-08-13
- US
DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
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…
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the states of CA, MA, PA and the…Official notice → - 2025-01-22
- US
DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
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)…
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of New Jersey and the…Official notice → - 2024-11-06
- US
DRG International, Inc. recalls 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone…
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…
FDA · DeviceDRG International, Inc.AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy…Official notice → - 2024-08-21
- US
DRG International, Inc. recalls Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative…
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.
FDA · DeviceDRG International, Inc.US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.Official notice → - 2022-04-13
- US
DRG International, Inc. recalls C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
- 2021-12-08
- US
DRG International, Inc. recalls Total Thyroxine (T4) ELISA; REF EIA-1781
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.
FDA · DeviceDRG International, Inc.Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG,…Official notice →