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DRG International Recalls
6 recalls on record · December 8, 2021 to August 13, 2025 · Medical Devices
Recalls by year
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 13, 2025Medical DevicesFDA
DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total
Hazard: 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).
January 22, 2025Medical DevicesFDA
DRG International, Inc. recalls DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Hazard: 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.
November 6, 2024Medical DevicesFDA
DRG International, Inc. recalls 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O
Hazard: 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.
August 21, 2024Medical DevicesFDA
DRG International, Inc. recalls Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo
Hazard: 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.
April 13, 2022Medical DevicesFDA
DRG International, Inc. recalls C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog #
Hazard: ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
December 8, 2021Medical DevicesFDA
DRG International, Inc. recalls Total Thyroxine (T4) ELISA; REF EIA-1781
Hazard: 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.