--- title: "Ortho-Clinical Diagnostics Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Ortho-Clinical Diagnostics recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/ortho-clinical-diagnostics/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Ortho-Clinical Diagnostics recall records **5** reported ongoing 5 records in this archive. Latest source date Feb 27, 2024. 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 Feb 27, 2024 FDA device enforcement ### [VITROS Performance Verifier I](https://isitonrecall.com/recall/fda-device-z-1372-2024-vitros-performance-verifier-i/) The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This i... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, M... [Official source for VITROS Performance Verifier I](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1372-2024%22) Feb 27, 2024 FDA device enforcement ### [VITROS Performance Verifier II](https://isitonrecall.com/recall/fda-device-z-1373-2024-vitros-performance-verifier-ii/) The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This i... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, M... [Official source for VITROS Performance Verifier II](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1373-2024%22) Jun 5, 2023 FDA device enforcement ### [VITROS Immunodiagnostic Products Troponin I ES Reagent Pack](https://isitonrecall.com/recall/fda-device-z-2357-2023-vitros-immunodiagnostic-products-troponin-i-es-reagent-pack/) Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Canada. [Official source for VITROS Immunodiagnostic Products Troponin I ES Reagent Pack](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2357-2023%22) Jun 5, 2023 FDA device enforcement ### [VITROS Immunodiagnostic Products Troponin I ES Calibrators](https://isitonrecall.com/recall/fda-device-z-2358-2023-vitros-immunodiagnostic-products-troponin-i-es-calibrators/) Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Canada. [Official source for VITROS Immunodiagnostic Products Troponin I ES Calibrators](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2358-2023%22) May 8, 2023 FDA device enforcement ### [VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems...](https://isitonrecall.com/recall/fda-device-z-2129-2023-vitros-chemistry-products-calibrator-kit-20-in-vitro-diagnostic-use-only-vitros-chemistry-products-c/) Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, ... [Official source for VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Produc...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2129-2023%22) ## Reasons in these listed records - The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive... - Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. - Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for... These examples come from this result page and are not a ranking of every recall reason. ## Checking Ortho-Clinical Diagnostics ### Is there a recall on ortho-clinical diagnostics right now? This archive contains 5 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 Ortho-Clinical Diagnostics](https://isitonrecall.com/check/?q=Ortho-Clinical%20Diagnostics) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)