Data / Medical devices / United States / Diagnostica Stago, Inc.
Diagnostica Stago, Inc.: FDA-registered device maker in Parsippany, NJ, United States, 103 510(k) clearances
Diagnostica Stago, Inc. is registered with the FDA (registration 2245451) in Parsippany, NJ, United States. It lists 33 device types. The FDA files 103 510(k) clearances under its listings, the newest dated April 27, 2026. 30 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2245451
- Address
- 5 Century Dr, Parsippany, NJ, United States, 07054
- Owner or operator
- Diagnostica Stago, Inc. (9003476)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- January 4, 2017
- Registered through
- 2027
- Brand names listed
- Asserachrom APA IgG,M, Asserachrom APA Screen, Asserachrom D-Di, Asserachrom Free Protein S, Asserachrom HPIA, Asserachrom HPIA - IgG, Asserachrom IX:Ag, Asserachrom PF4 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 103.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2026 | K253658 | STA Satellite Max® | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| June 7, 2023 | K212183 | STA R Max 3, STA Compact Max 3 | JPA | Substantially Equivalent | Diagnostica Stago S.A.S | accessdata.fda.gov |
| June 2, 2023 | K220728 | vWF Ag | GGP | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| December 23, 2022 | K211485 | STA- NeoPTimal | GJS | Substantially Equivalent | Diagnostica Stago S.A.S | accessdata.fda.gov |
| December 10, 2016 | K162227 | STA® - Liatest® D-Di | DAP | Substantially Equivalent | Diagnostica Stago | accessdata.fda.gov |
| August 7, 2015 | K151867 | STA R MAX | JPA | Substantially Equivalent | Diagnostica Stago S.A.S | accessdata.fda.gov |
| December 12, 2014 | K142132 | POOL NORM | GGN | Substantially Equivalent | Diagnostics Stago S.A.S. | accessdata.fda.gov |
| September 3, 2014 | K141144 | STA LIATEST D-DI | DAP | Substantially Equivalent | Diagnostica Stago | accessdata.fda.gov |
| March 14, 2013 | K120014 | STA- COAG CONTROL (N+ABN) PLUS | GGN | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| February 12, 2013 | K130090 | STA COMPACT MAX | JPA | Substantially Equivalent | Diagnostica Stago, Incorporated | accessdata.fda.gov |
| October 26, 2011 | K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | KFF | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| December 18, 2009 | K093001 | STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Incorporated | accessdata.fda.gov |
| July 2, 2009 | K083896 | DESTINY MAX COAGULATION ANALYZER | JPA | Substantially Equivalent | Trinity Biotech | accessdata.fda.gov |
| December 12, 2008 | K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| December 6, 2006 | K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | GIR | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| July 28, 2006 | K061803 | STA - CONTROL LA 1+2 | GGC | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| August 30, 2002 | K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | JPA | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| November 15, 2001 | K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | DAP | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| November 15, 2001 | K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | DAP | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| June 6, 2001 | K010963 | STA-LIATEST FREE PROTEIN S TEST KIT | GGP | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| April 9, 2001 | K010324 | STA-QUALITY HBPM/LMWH KIT | GGN | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| March 15, 2001 | K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | DAP | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| March 1, 2001 | K003328 | ACCUCLOT CONTROL I, MODEL A4089 | GIZ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| February 12, 2001 | K003767 | ASSERACHROM HPIA TEST KIT | LCO | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| April 7, 2000 | K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | GIR | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| April 7, 2000 | K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | GIR | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| November 12, 1998 | K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 9, 1997 | K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | KQJ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| August 19, 1997 | K971519 | ASSERACHROM TPA TEST KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| July 25, 1997 | K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | JBQ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| June 26, 1997 | K964728 | STA-LIATEST D-DI TEST KIT | DAP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| June 26, 1997 | K964716 | STA LIATEST CONTROL [N]+[P] KIT | GGN | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| November 18, 1996 | K963106 | CHROMOLIZE PAI-1 KIT | GGP | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| October 25, 1996 | K962675 | STA - LIATEST VWF TEST KIT | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| September 13, 1996 | K962671 | STA-VWF CALIBRATOR KIT | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| August 14, 1996 | K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | JBQ | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 5, 1996 | K960438 | TINTELIZE PAI-1 KIT | GGP | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| May 24, 1996 | K961370 | LA POSITIVE CONTROL PLASMA | GGC | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| March 12, 1996 | K955724 | KC 1A COAGULATION ANALYZER/SET | JPA | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| March 11, 1996 | K955735 | KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM | JPA | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| November 13, 1995 | K954040 | ASSERACHROM TOTAL PROTEIN S KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| November 13, 1995 | K954017 | ASSERACHROM FREE PROTEIN S KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| September 26, 1995 | K943520 | HEPARIN CONTROL KIT | KFF | Unknown | American Bioproducts Co. | accessdata.fda.gov |
| September 26, 1995 | K943519 | HBPM/LMWH CONTROL KIT | KFF | Unknown | American Bioproducts Co. | accessdata.fda.gov |
| September 26, 1995 | K943514 | THE HEPANORM HBPM/LMWH KIT | KFF | Unknown | American Bioproducts Co. | accessdata.fda.gov |
| May 23, 1995 | K925433 | THE STACHROM HEPARIN ASSAY KIT | KFF | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| May 11, 1995 | K943517 | STACLOT HEPARIN TEST KIT | KFF | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| March 21, 1995 | K943518 | STA SYSTEM CONTROL [N] + [P] KIT | GGN | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| May 17, 1994 | K935308 | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY | JBQ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| March 1, 1994 | K934606 | STAGO FACTOR II-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| March 1, 1994 | K934605 | STAGO FACTOR V-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| December 6, 1993 | K934584 | SPECTROLYSE FACTOR VII:C | GGP | Substantially Equivalent | Meditech, Inc. | accessdata.fda.gov |
| November 15, 1993 | K933432 | STAGO FACTOR IX-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| November 5, 1993 | K931906 | NEW STACHROM PROTEIN C TEST KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 27, 1993 | K933444 | STAGO FACTOR XI-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 27, 1993 | K933441 | STAGO FACTOR X-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 27, 1993 | K933440 | STAGO FACTOR VII-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 27, 1993 | K933438 | STAGO FACTOR XII-DEFICIENT PLASMA | GJT | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| April 20, 1993 | K930849 | VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA | JPA | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| December 23, 1992 | K923731 | STACLOT LA TEST KIT | GFO | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 19, 1992 | K921396 | PLATELIN L | GFO | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| October 16, 1992 | K920668 | MINUTEX D-DIMER LATEX TEST | GHH | Substantially Equivalent | Biopool AB | accessdata.fda.gov |
| July 13, 1992 | K920943 | FDP PLASMA TEST KIT | DAP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| June 23, 1992 | K922040 | NEOPLASTINE CI PLUS | GJS | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| June 9, 1992 | K922021 | UNICALIBRATOR KIT | GIZ | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| June 9, 1992 | K921684 | PTT-LA TEST KIT | GGW | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 8, 1991 | K913424 | STACLOT(R) PROTEIN S TEST KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 2, 1991 | K912468 | LIATEST PROTEIN S KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| January 24, 1991 | K905110 | LIATEST(R) AT III TEST KIT | JBQ | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| November 13, 1990 | K904297 | ST-4 COAGULATION INSTRUMENT | GKP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| October 22, 1990 | K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | GGC | Substantially Equivalent | Medi-Tech, Inc. | accessdata.fda.gov |
| March 27, 1990 | K900792 | RISTOCETIN | GHR | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| January 25, 1990 | K900133 | FACTOR II DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| November 9, 1989 | K896052 | FIBRINOGEN ASSAY KIT | KQJ | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| October 6, 1989 | K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT | GFO | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893536 | FACTOR XI DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893535 | FACTOR VII DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893534 | FACTOR XII DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893533 | FACTOR V DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893525 | FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893524 | FACTOR IX DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893523 | FACTOR X DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K892859 | THE STAGO VIII DEFICIENT PLASMA KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| February 7, 1989 | K890399 | MODIFIED D-DI-TEST KIT | GHH | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| December 28, 1988 | K884384 | THROMBIN-PREST REAGENT KIT | GJA | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| August 17, 1988 | K881999 | PLATELIN(R) EXCEL L | GIT | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| July 1, 1988 | K882214 | SIMPLASTIN EXCEL S | GJS | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| May 2, 1988 | K881348 | VERIFY(R) REFERENCE PLASMA | GGN | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| October 22, 1986 | K862775 | ASSERACHROM B-TG KIT | JBX | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| September 16, 1986 | K862156 | ASSERACHROM D-DI KIT | DAP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| September 4, 1986 | K862774 | ASSERACHROM PF4 KIT | LCO | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| June 23, 1986 | K861190 | PTT AUTOMATE TEST KIT | GGW | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| June 19, 1986 | K861079 | STACLOT PROTEIN C TEST KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| April 4, 1986 | K860371 | ASSERACHROM VWF KIT | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| March 6, 1986 | K854015 | FS TEST KIT | JBN | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| March 3, 1986 | K854762 | HEPANORM CALIBRATION PLASMA SET | KFF | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| February 4, 1986 | K854312 | ASSERACHROM IX:AG | GGP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| January 3, 1986 | K854016 | ASSERACHROM PROTEIN C KIT | JLA | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| April 23, 1984 | K840210 | REPTILASE-R HA35 | JCO | Substantially Equivalent | Wellcome Diagnostics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 29, 2026 | 99531 | Class II | Ongoing | 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 | accessdata.fda.gov |
| February 5, 2026 | 98362 | Class II | Ongoing | 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 i | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. | accessdata.fda.gov |
| February 4, 2026 | 98394 | Class II | Ongoing | 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 f | 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. | accessdata.fda.gov |
| December 15, 2025 | 98163 | Class II | Ongoing | 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 hep | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. | accessdata.fda.gov |
| September 12, 2025 | 97596 | Class II | Ongoing | Product: STA Liatest D-Di; REF: 00515 | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. | accessdata.fda.gov |
| July 21, 2025 | 97287 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 21, 2025 | 96937 | Class II | Ongoing | 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 | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% | accessdata.fda.gov |
| March 22, 2023 | 92007 | Class II | Ongoing | 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). | accessdata.fda.gov |
| March 4, 2020 | 85167 | Class II | Terminated | 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 platf | 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 | accessdata.fda.gov |
| November 18, 2019 | 84402 | Class II | Terminated | 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. | accessdata.fda.gov |
| November 14, 2018 | 81678 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| July 24, 2018 | 80826 | Class II | Terminated | 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 | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) | accessdata.fda.gov |
| October 25, 2017 | 79292 | Class II | Terminated | 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%). | accessdata.fda.gov |
| July 18, 2014 | 69070 | Class III | Terminated | 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 unfractionat | Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. | accessdata.fda.gov |
| January 28, 2013 | 64320 | Class II | Terminated | Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. | accessdata.fda.gov |
| June 15, 2012 | 63270 | Class II | Terminated | STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coag | Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite. | accessdata.fda.gov |
| August 23, 2011 | 61019 | Not yet classified | Terminated | STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAb | Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P. | accessdata.fda.gov |
| October 20, 2008 | 50125 | Not yet classified | Terminated | STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France. | Internal investigation has determined the potential lack of homogeneity between product vials. | accessdata.fda.gov |
| July 30, 2007 | 39419 | Not yet classified | Terminated | STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. | Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message. | accessdata.fda.gov |
| May 8, 2007 | 37952 | Not yet classified | Terminated | STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex | Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit. | accessdata.fda.gov |
| March 30, 2007 | 37834 | Not yet classified | Terminated | STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT). | Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN. | accessdata.fda.gov |
| March 13, 2007 | 37746 | Not yet classified | Terminated | STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor. | A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%. | accessdata.fda.gov |
| January 18, 2007 | 37868 | Not yet classified | Terminated | STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France | Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors. | accessdata.fda.gov |
| July 18, 2006 | 35946 | Not yet classified | Terminated | Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay. | Decrease in sensitivity; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. | accessdata.fda.gov |
| October 26, 2005 | 34011 | Not yet classified | Terminated | STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method. | The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range. | accessdata.fda.gov |
| June 20, 2005 | 32714 | Not yet classified | Terminated | STA-R blood coagulation analyzer. Catalog Number 57160. | Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process. | accessdata.fda.gov |
| April 13, 2005 | 32494 | Not yet classified | Terminated | PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054. | Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent. | accessdata.fda.gov |
| March 5, 2003 | 25823 | Not yet classified | Terminated | STA-Compact Hemostasis System with Cap piercing capability. | With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury. | accessdata.fda.gov |
| December 20, 2002 | 29169 | Not yet classified | Terminated | STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of | Incorrect assay ranges on the assay value insert for Heparin Control 5. | accessdata.fda.gov |
| December 4, 2002 | 29178 | Not yet classified | Terminated | FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit cont | The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs. | accessdata.fda.gov |
Compare with other makers
- All makers of Plasma, Coagulation Factor Deficient
- All makers of Factor Xiii A, S, Antigen, Antiserum, Control
- All makers of Test, Time, Prothrombin
- All makers of Assay, Heparin
- All makers of Fibrin Split Products
- All makers of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Updated August 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.