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DRG International, Inc. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total Class IIIJun 4, 2025An incoming complaint reported that the expiration date on t |
| DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361Class IIOct 7, 2024The user of the assay may either face a failure message duri |
| 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OClass IIISep 13, 2024The High and Low Control acceptance ranges in the Certificat |
| Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay foClass IIIJul 5, 2024Invalid Controls. The Low Control is out of range; too high |
| C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog #Class IIDec 21, 2021ODs of the standards too low(< 0.6 ODmax) may cause invalid |
| Total Thyroxine (T4) ELISA; REF EIA-1781Class IIOct 18, 2021Firm has identified two lots of product that do not meet pro |