Diagnostica Stago, Inc.
Complete recall history across all FDA and CPSC categories — 26 total recalls
Diagnostica Stago, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (26)
FDA medical device enforcement actions by Diagnostica Stago, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 5, 2026 | Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog N... | After receiving customer complaints, investigations confirmed the presence of... | Class II |
| Feb 4, 2026 | Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protei... | The potential of out-of-range results and an underestimation of the free prot... | Class II |
| Dec 15, 2025 | Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit ... | Potential for defect for Asserachrom HPIA lot 271288, which can affect every ... | Class II |
| Sep 12, 2025 | Product: STA Liatest D-Di; REF: 00515; | A potential risk of underestimation of D-Dimer (D-Di) levels with the two lis... | Class II |
| Jul 21, 2025 | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagent... | Class II |
| Jul 21, 2025 | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagent... | Class II |
| Jul 21, 2025 | STA Satellite. Product Code: All references. All software versions. The ST... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagent... | Class II |
| Jul 21, 2025 | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagent... | Class II |
| May 21, 2025 | STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a bu... | Potential for shorter clotting times in clotting tests which have a dilution,... | Class II |
| Mar 22, 2023 | STA R Max fully automatic clinical instrument designed to perform tests on hu... | An internal investigation identified a bug in this firmware version, resultin... | Class II |
| Mar 22, 2023 | STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 an... | An internal investigation identified a bug in this firmware version, resultin... | Class II |
| Mar 22, 2023 | STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and ... | An internal investigation identified a bug in this firmware version, resultin... | Class II |
| Mar 4, 2020 | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno... | A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII ... | Class II |
| Nov 18, 2019 | STA UNICALIBRATOR (ref. 00675) | A positive bias was confirmed to exists on the STA - Unicalibrator levels wit... | Class II |
| Nov 18, 2019 | STA SYSTEM CONROL N + P (ref. 00678) | A positive bias was confirmed to exists on the STA - Unicalibrator levels wit... | Class II |
| Nov 14, 2018 | Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are ... | There have been reports of shortened (T1-T2) results, where some instances of... | Class II |
| Nov 14, 2018 | Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits ar... | There have been reports of shortened (T1-T2) results, where some instances of... | Class II |
| Jul 24, 2018 | Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic... | QC values outside of the assigned ranges (prolonged Prothrombin time / decrea... | Class II |
| Jul 24, 2018 | Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for d... | QC values outside of the assigned ranges (prolonged Prothrombin time / decrea... | Class II |
| Oct 25, 2017 | Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated de... | Confirmed defect of homogeneity where some reagent vials will give prolonged ... | Class II |
| Oct 25, 2017 | STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated d... | Confirmed defect of homogeneity where some reagent vials will give prolonged ... | Class II |
| Oct 25, 2017 | Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated d... | Confirmed defect of homogeneity where some reagent vials will give prolonged ... | Class II |
| Oct 25, 2017 | STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automa... | Confirmed defect of homogeneity where some reagent vials will give prolonged ... | Class II |
| Jul 18, 2014 | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kit... | Diagnostica Stago Inc. received some customer complaints regarding a misreadi... | Class III |
| Jan 28, 2013 | Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATES... | Diagnostica Stago has confirmed that sometimes the delta OD measured can be c... | Class II |
| Jun 15, 2012 | STA Satellite Automated Multi-Parameter Analyzer This system is a fully au... | Following a single customer complaint that incorrect INR values were occasion... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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