--- title: "DRG International, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search DRG International, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/drg-international-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # DRG International, Inc. recall records **5** reported ongoing 6 records in this archive. Latest source date Jun 4, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 4, 2025 FDA device enforcement ### [Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA](https://isitonrecall.com/recall/fda-device-z-2265-2025-brand-name-t4-total-elisa-product-name-t4-total-elisa-model-catalog-number-eia-4568-product-descript/) 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 dat... Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova. [Official source for Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product De...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2265-2025%22) Oct 7, 2024 FDA device enforcement ### [DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361](https://isitonrecall.com/recall/fda-device-z-0921-2025-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) which causes a delay in results. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania. [Official source for DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0921-2025%22) Sep 13, 2024 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-0258-2025-17-oh-progesterone-elisa-96-well-kit-an-enzyme-immunoassay-for-the-quantitative-in-vitro-diagnostic/) 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 dela... Class III Reported ongoing Distribution: AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam [Official source for 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnos...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0258-2025%22) Jul 5, 2024 FDA device enforcement ### [Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free ...](https://isitonrecall.com/recall/fda-device-z-2622-2024-product-name-salivary-testosterone-elisa-model-catalog-number-slv-3013-product-description-an-enzyme/) 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. Class III Reported ongoing Distribution: US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA. [Official source for Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2622-2024%22) Dec 21, 2021 FDA device enforcement ### [C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293](https://isitonrecall.com/recall/fda-device-z-0896-2022-c-peptide-elisa-ivd-measurement-of-c-peptide-in-serum-plasma-edta-heparin-or-citrate-plasma-and-urin/) ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible Class II Reported terminated Distribution: NY [Official source for C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasm...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0896-2022%22) Oct 18, 2021 FDA device enforcement ### [Total Thyroxine (T4) ELISA; REF EIA-1781](https://isitonrecall.com/recall/fda-device-z-0310-2022-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. Class II Reported ongoing Distribution: Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM [Official source for Total Thyroxine (T4) ELISA; REF EIA-1781](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0310-2022%22) ## Reasons in these listed records - 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 lab... - 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. - 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 ... - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking DRG International, Inc. ### Is there a recall on drg international, inc. right now? This archive contains 6 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search DRG International, Inc.](https://isitonrecall.com/check/?q=DRG%20International%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)