--- title: "VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITR... — FDA record Z-2073-2025 | Is It on Recall" description: "Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable t" url: https://isitonrecall.com/recall/fda-device-z-2073-2025-vitros-chemistry-products-op-reagent-gen-15-model-number-680-1997-the-vitros-op-reagent-is-a-dual-ch/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered packag... — FDA record Z-2073-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jun 12, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. 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/). ## What the record says - **Product**: VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests. - **Reason**: Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results. - **Classification**: Class II - **Recalling firm**: Ortho-Clinical Diagnostics, Inc. - **Quantity**: 2,017 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2073-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2073-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model Number: 680 1997. UDI-DI: 10758750001835. Lot Numbers: 1527-15-2749 (exp. 17-Nov-2025), 1527-15-2771 (exp. 17-Dec-2025), 1527-15-2818 (exp. 11-Apr-2026), 1527-15-2871 (exp. 15-May-2026). | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2073-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ortho-Clinical Diagnostics, Inc. records](https://isitonrecall.com/brand/ortho-clinical-diagnostics-inc/)