--- title: "Diagnostica Stago, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Diagnostica Stago, 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/diagnostica-stago-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Diagnostica Stago, Inc. recall records **13** reported ongoing 13 records in this archive. Latest source date Jul 29, 2026. 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 Jul 29, 2026 FDA device enforcement ### [STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test](https://isitonrecall.com/recall/fda-device-z-3047-2026-sta-staclot-protein-s-model-catalog-number-00746-reagent-lot-number-273074-qualitative-and-quantitat/) A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified Class II Reported ongoing Distribution: US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR. [Official source for STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and qua...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3047-2026%22) Feb 5, 2026 FDA device enforcement ### [Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for ...](https://isitonrecall.com/recall/fda-device-z-1585-2026-brand-name-sta-liatest-d-di-product-name-sta-liatest-d-di-model-catalog-number-ref-00515-product-des/) After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia. [Official source for Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1585-2026%22) Feb 4, 2026 FDA device enforcement ### [Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits ar...](https://isitonrecall.com/recall/fda-device-z-1491-2026-brand-name-sta-liatest-free-protein-s-product-name-sta-liatest-free-protein-s-model-catalog-number-r/) The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ... [Official source for Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Num...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1491-2026%22) Dec 15, 2025 FDA device enforcement ### [Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) ...](https://isitonrecall.com/recall/fda-device-z-1084-2026-asserachrom-hpia-model-catalog-number-00615-the-asserachrom-hpia-kit-is-intended-for-the-qualitative/) Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Fin... [Official source for Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the quali...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1084-2026%22) Sep 12, 2025 FDA device enforcement ### [Product: STA Liatest D-Di; REF: 00515;](https://isitonrecall.com/recall/fda-device-z-0205-2026-product-sta-liatest-d-di-ref-00515/) A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. Class II Reported ongoing Distribution: Worldwide distribution- US Nationwide and the country of Canada. [Official source for Product: STA Liatest D-Di; REF: 00515;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0205-2026%22) Jul 21, 2025 FDA device enforcement ### [STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chrom...](https://isitonrecall.com/recall/fda-device-z-2473-2025-sta-satellite-product-code-all-references-all-software-versions-the-sta-satellite-is-a-fully-automat/) Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Arge... [Official source for STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2473-2025%22) Jul 21, 2025 FDA device enforcement ### [STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative...](https://isitonrecall.com/recall/fda-device-z-2474-2025-sta-liquid-anti-xa-4-model-catalog-number-00311us-the-sta-liquid-anti-xa-kits-are-intended-for-use-w/) Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Arge... [Official source for STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2474-2025%22) Jul 21, 2025 FDA device enforcement ### [STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative...](https://isitonrecall.com/recall/fda-device-z-2475-2025-sta-liquid-anti-xa-8-model-catalog-number-00322us-the-sta-liquid-anti-xa-kits-are-intended-for-use-w/) Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Arge... [Official source for STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2475-2025%22) Jul 21, 2025 FDA device enforcement ### [STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the q...](https://isitonrecall.com/recall/fda-device-z-2476-2025-sta-fibrinogen-5-model-catalog-number-00674-the-sta-fibrinogen-5-kit-is-intended-for-use-with-the-an/) Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Arge... [Official source for STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use w...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2476-2025%22) May 21, 2025 FDA device enforcement ### [STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests perform...](https://isitonrecall.com/recall/fda-device-z-1993-2025-sta-owren-koller-model-catalog-number-00360-sta-owren-koller-is-a-buffer-solution-intended-for-use-a/) Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% Class II Reported ongoing Distribution: The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was pr... [Official source for STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1993-2025%22) Mar 22, 2023 FDA device enforcement ### [STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026](https://isitonrecall.com/recall/fda-device-z-1575-2023-sta-r-max-fully-automatic-clinical-instrument-designed-to-perform-tests-on-human-plasmas-reference-n/) An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13). Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. [Official source for STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Referen...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1575-2023%22) Mar 22, 2023 FDA device enforcement ### [STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612](https://isitonrecall.com/recall/fda-device-z-1576-2023-sta-compact-automated-multi-parametric-analyzer-reference-numbers-58602-and-58612/) An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13). Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. [Official source for STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1576-2023%22) Mar 22, 2023 FDA device enforcement ### [STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612](https://isitonrecall.com/recall/fda-device-z-1577-2023-sta-compact-max-fully-automatic-clinical-analyzer-reference-numbers-58602-and-58612/) An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13). Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. [Official source for STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1577-2023%22) ## Reasons in these listed records - A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified - After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. - The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. - Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. These examples come from this result page and are not a ranking of every recall reason. ## Checking Diagnostica Stago, Inc. ### Is there a recall on diagnostica stago, inc. right now? This archive contains 13 records, including 13 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 Diagnostica Stago, Inc.](https://isitonrecall.com/check/?q=Diagnostica%20Stago%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)