Drg International recalls
Drg International appears in 7 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 7 |
|---|---|
| Published | 2021-12-08 to 2026-10-14 |
| By agency | FDA Device (7) |
| By classification | Class II (4), Class III (3) |
| By status | ongoing (6), terminated (1) |
| Distribution named in notices | AZ, CA, CO, DE, GA, NH, NY, US |
Recalls
- Sperm Ab ELISA
FDA Device · Class II · 2026-10-14 · Drg International
Reason: Potential for false negative patient results. - Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Device · Class III · 2025-08-13 · Drg International
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 inst… - DRG:HYBRiD-XL Insulin
FDA Device · Class II · 2025-01-22 · Drg International
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) whic… - 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-…
FDA Device · Class III · 2024-11-06 · Drg International
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 provi… - Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in…
FDA Device · Class III · 2024-08-21 · Drg International
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. - C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine
FDA Device · Class II · 2022-04-13 · Drg International
Reason: ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible - Total Thyroxine (T4) ELISA
FDA Device · Class II · 2021-12-08 · Drg International
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.