Diagnostica Stago, Inc.
Parsippany, NJ, US
DIAGNOSTICA STAGO, INC. appears in FDA device records in Parsippany, NJ. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 42 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Diagnostica Stago, Inc. between 2001 and 2026. The busiest year on record is 2001, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 5 |
| 2006 | 3 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253658 | STA Satellite Max® | JPA | Substantially Equivalent | |
| K162227 | STA® - Liatest® D-Di | DAP | Substantially Equivalent | |
| K141144 | STA LIATEST D-DI | DAP | Substantially Equivalent | |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | GGN | Substantially Equivalent | |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | KFF | Substantially Equivalent | |
| K092937 | STA-HYBRID HEP CALIBRATOR | JIT | Substantially Equivalent | |
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | |
| K092170 | STA LIATEST FREE PS | GGP | Substantially Equivalent | |
| K092113 | STA - FREE PS CALIBRATOR | JIX | Substantially Equivalent | |
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | JPA | Substantially Equivalent | |
| K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | GIR | Substantially Equivalent | |
| K061803 | STA - CONTROL LA 1+2 | GGC | Substantially Equivalent | |
| K053111 | STA-CEPHASCREEN KIT | GFO | Substantially Equivalent | |
| K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | KFF | Substantially Equivalent | |
| K010963 | STA-LIATEST FREE PROTEIN S TEST KIT | GGP | Substantially Equivalent | |
| K010350 | STA -CALIBRATOR HBPM/LMWH KIT | GGN | Substantially Equivalent | |
| K010324 | STA-QUALITY HBPM/LMWH KIT | GGN | Substantially Equivalent | |
| K003767 | ASSERACHROM HPIA TEST KIT | LCO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2245451 | 2245451 | DIAGNOSTICA STAGO, INC. | 5 Century Dr, PARSIPPANY, NJ 07054 US | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFOActivated Partial Thromboplastin
- JBXAggregrometer, Platelet
- JBQAntithrombin Iii Quantitation
- KFFAssay, Heparin
- JCOBothrops Atrox Reagent
- JQPCalculator/Data Processing Module, For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- GGCControl, Plasma, Abnormal
- JLAConversion To Creatinine, Creatine
- DBTFactor Xiii A, S, Antigen, Antiserum, Control
- JBNFibrin Monomer Paracoagulation
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- GKPInstrument, Coagulation, Automated
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- DDXPlasminogen, Antigen, Antiserum, Control
- LCOPlatelet Factor 4 Radioimmunoassay
- GITReagent & Control, Partial Thromboplastin Time
- GHRReagent, Platelet Aggregation
- GIRReagent, Russel Viper Venom
- OTRResearch Use Only/Immunology Devices
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KQJSystem, Fibrinogen Determination
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
Recall records
Showing 25 of 42| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3047-2026 | STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test | A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified | Class II | Open, Classified | |
| Z-1585-2026 | 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 the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. | Class II | Open, Classified | |
| Z-1491-2026 | 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 are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable | 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 | Open, Classified | |
| Z-1084-2026 | 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) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA. | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. | Class II | Open, Classified | |
| 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 | Open, Classified | |
| Z-2476-2025 | 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 quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Class II | Open, Classified | |
| Z-2475-2025 | 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 determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Class II | Open, Classified | |
| Z-2474-2025 | 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 determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Class II | Open, Classified | |
| Z-2473-2025 | STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Class II | Open, Classified | |
| Z-1993-2025 | 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 performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families. | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% | Class II | Open, Classified | |
| 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 | Open, Classified | |
| 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 | Open, Classified | |
| Z-1575-2023 | STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 | 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 | Open, Classified | |
| Z-1699-2020 | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979 | A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased | Class II | Terminated | |
| Z-0738-2020 | STA SYSTEM CONROL N + P (ref. 00678) | A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results. | Class II | Terminated | |
| Z-0737-2020 | STA UNICALIBRATOR (ref. 00675) | A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results. | Class II | Terminated | |
| Z-0611-2019 | Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2). | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. | Class II | Terminated | |
| Z-0610-2019 | Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2). | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. | Class II | Terminated | |
| Z-2994-2018 | Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA - Noplastine CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875). | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) | Class II | Terminated | |
| Z-2993-2018 | Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875). | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) | Class II | Terminated | |
| Z-1069-2018 | STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT). | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Class II | Terminated | |
| Z-1068-2018 | STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT). | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Class II | Terminated | |
| Z-1067-2018 | Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT). | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Class II | Terminated | |
| Z-1066-2018 | Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT). | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Class II | Terminated | |
| Z-2650-2014 | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. | Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. | Class III | Terminated |
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