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Sign in to claim this brandDIAGNOSTICA STAGO
France·FR-MF-000017089
Last updated May 23, 2026
What DIAGNOSTICA STAGO makes
Diagnostica Stago manufactures in vitro diagnostic (IVD) reagents and instruments for coagulation testing, including assays for immune deficiency markers (e.g., ImmunoDef II, ImmunoDef XII), von Willebrand factor (VWF:FVIIIB, VWF:CB), protein C, and epinephrine. Their portfolio also includes clotting reagents (e.g., Néoplastine® CI Plus 5, Collagen) and anticoagulant monitoring solutions (e.g., sthemO Anti-Xa M). The company produces both manual test kits (e.g., Asserachrom® series) and automated systems (e.g., STA Compact Max® 2) for laboratory use.
The company’s products are regulated under IVD General (Class A, B, C) and Class II classifications in the EU and FDA’s 510(k) pathway in the US. Devices are listed in the EU’s eudamed registry and the FDA’s 510(k) database. The manufacturer is based in France.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- France
- Address
- 3, allée Thérésa, Asnières sur Seine, France
- Website
- stago.com
- —
- —
- [email protected]
- Phone
- +33 (0)1 46 88 20 20
- PRRC Contact
- Sophie REHAULT
- EUDAMED SRN
- FR-MF-000017089
- FDA FEI Number
- —
- DUNS Number
- 262277122
Catalogue (153)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| STA® - Microcups | 00802 | EUDAMED | Class A | Active |
| STA® - Edoxaban Control | 01072 | EUDAMED | Class C | Active |
| STA® - Liatest® Free Protein S 6 | 00516 | EUDAMEDFDA UDI | Class B | Active |
| STA® - Hepato-Prest 4 | 00761 | EUDAMED | Class C | Active |
| sthemO VII | 01231 | EUDAMED | Class B | Active |
| STA® - Fibrinogen 5 | 00674 | EUDAMEDFDA UDI | Class B | Active |
| Asserachrom® Free Protein S | 00946 | EUDAMEDFDA UDI | IVD General | Active |
| sthemO Cleaner | 01266 | EUDAMED | Class A | Active |
| STA Compact Max® 3 | 59023 | EUDAMED | Class A | Active |
| STA® - Deficient V | 00744 | EUDAMEDFDA UDI | Class B | Active |
| STA R Max® 3 | 59020 | EUDAMED | Class A | Active |
| sthemO mini Reducer | 01351 | EUDAMED | Class A | Active |
| STA® - maxi Reducer | 00801 | EUDAMED | Class A | Active |
| sthemO Owren Koller M | 01463 | EUDAMED | Class A | Active |
| STA R Max® 3 | 59029 | EUDAMED | Class A | Active |
| sthemO Microcups | 01523 | EUDAMED | Class A | Active |
| STA® - Dabigatran Calibrator | 00993 | EUDAMED | Class C | Active |
| STA® - Cleaner Solution | 00973 | EUDAMEDFDA UDI | Class A | Active |
| sthemO 201 | 59032 | EUDAMED | Class A | Active |
| STA® - NeoPTimal 10 | 01164 | EUDAMED | Class C | Active |
| ST Genesia® | 86814 | EUDAMED | Class A | Active |
| STA R Max® 3 | 59031 | EUDAMED | Class A | Active |
| STA® - Staclot® dRVV Screen 2 | 00339 | EUDAMEDFDA UDI | Class B | Active |
| STA® - Routine QC 2 ml | 00554 | EUDAMED | Class C | Active |
| sthemO Daily QC 1&2 | 01255 | EUDAMED | Class C | Active |
| sthemO PS VWF QC 1&2 | 01252 | EUDAMED | Class B | Active |
| STA® - Liquid Anti-Xa 8 | 00322 | EUDAMED | Class C | Active |
| sthemO Heparin cal | 01248 | EUDAMED | Class C | Active |
| sthemO X | 01232 | EUDAMED | Class B | Active |
| sthemO dRVV screen M | 01237 | EUDAMED | Class B | Active |
| sthemA CTR-L2 | 01402 | EUDAMED | Class B | Active |
| STG® - Cuvettes | 86800 | EUDAMED | Class A | Active |
| sthemA CTR-L1 | 01401 | EUDAMED | Class B | Active |
| STA® - Thrombin 10 | 00669 | EUDAMEDFDA UDI | Class B | Active |
| sthemO LMWH QC 1&2 | 01250 | EUDAMED | Class C | Active |
| sthemO 301 | 59018 | EUDAMED | Class A | Active |
| STA® - Liatest® FM | 00543 | EUDAMED | Class B | Active |
| STA® - Liatest® FDP | 00649 | EUDAMED | Class B | Active |
| STA R Max® 2 | 59013 | EUDAMEDFDA UDI | Class A | Active |
| STA® - Multi Hep Calibrator | 00348 | EUDAMEDFDA UDI | Class C | Active |
| Citrate Buffer | 00890 | EUDAMED | Class A | Active |
| STA R Max® 2 | 59012 | EUDAMED | Class A | Active |
| sthemO V | 01230 | EUDAMED | Class B | Active |
| STart Max | 59041 | EUDAMED | Class A | Active |
| sthemO VIII | 01225 | EUDAMED | Class B | Active |
| sthemO AT L | 01303 | EUDAMED | Class B | Active |
| STA® - Edoxaban Calibrator | 01073 | EUDAMED | Class C | Active |
| STA® - Coag Control N + P | 00679 | EUDAMED | Class C | Active |
| sthemO PS clot | 01242 | EUDAMED | Class B | Active |
| sthemO PT M | 01218 | EUDAMED | Class C | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (41)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Diagnostica Stago has initiated 41 recall records between December 4, 2002, and February 5, 2026, with statuses recorded as open, classified, or terminated. The reasons cited include assay inaccuracies (e.g., incorrect ranges, homogeneity defects, and clotting time discrepancies), measurement biases (e.g., positive or negative bias in D-Dimer, factor VIII/IX, and EQA results), potential contamination or cross-reactivity (e.g., sample contamination in Emicizumab assays or reagent cross-contamination), instrument failures (e.g., silicon bridge rectifier defects causing smoke and burnt components), and lot-specific performance issues (e.g., low results in Free Protein S assays or altered optical density measurements).
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 5, 2026 | Z-1585-2026 | — | open, classified | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. |
| Feb 4, 2026 | Z-1491-2026 | — | open, classified | 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. |
| Dec 15, 2025 | Z-1084-2026 | — | open, classified | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. |
| Sep 12, 2025 | Z-0205-2026 | — | open, classified | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. |
| Jul 21, 2025 | Z-2474-2025 | — | open, classified | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| Jul 21, 2025 | Z-2476-2025 | — | open, classified | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| Jul 21, 2025 | Z-2473-2025 | — | open, classified | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| Jul 21, 2025 | Z-2475-2025 | — | open, classified | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| May 21, 2025 | Z-1993-2025 | — | open, classified | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% |
| Mar 22, 2023 | Z-1575-2023 | — | open, classified | 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). |
| Mar 22, 2023 | Z-1576-2023 | — | open, classified | 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). |
| Mar 22, 2023 | Z-1577-2023 | — | open, classified | 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). |
| Mar 4, 2020 | Z-1699-2020 | — | terminated | 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 |
| Nov 18, 2019 | Z-0737-2020 | — | terminated | 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. |
| Nov 18, 2019 | Z-0738-2020 | — | terminated | 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. |
| Nov 14, 2018 | Z-0611-2019 | — | terminated | 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. |
| Nov 14, 2018 | Z-0610-2019 | — | terminated | 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. |
| Jul 24, 2018 | Z-2993-2018 | — | terminated | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) |
| Jul 24, 2018 | Z-2994-2018 | — | terminated | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) |
| Oct 25, 2017 | Z-1067-2018 | — | terminated | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). |
| Oct 25, 2017 | Z-1066-2018 | — | terminated | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). |
| Oct 25, 2017 | Z-1069-2018 | — | terminated | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). |
| Oct 25, 2017 | Z-1068-2018 | — | terminated | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). |
| Jul 18, 2014 | Z-2650-2014 | — | terminated | Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. |
| Jan 28, 2013 | Z-0951-2013 | — | terminated | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. |
| Jun 15, 2012 | Z-0252-2013 | — | terminated | 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. |
| Aug 23, 2011 | Z-1044-2012 | — | terminated | Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P. |
| Oct 20, 2008 | Z-0502-2009 | — | terminated | Internal investigation has determined the potential lack of homogeneity between product vials. |
| Oct 20, 2008 | Z-0501-2009 | — | terminated | Internal investigation has determined the potential lack of homogeneity between product vials. |
| Jul 30, 2007 | Z-0039-2008 | — | terminated | 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. |
| May 8, 2007 | Z-1072-2007 | — | terminated | Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit. |
| Mar 30, 2007 | Z-0979-2007 | — | terminated | 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. |
| Mar 13, 2007 | Z-0853-2007 | — | terminated | 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%. |
| Jan 18, 2007 | Z-0812-2007 | — | terminated | 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. |
| Jul 18, 2006 | Z-1441-06 | — | terminated | Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. |
| Oct 26, 2005 | Z-0408-06 | — | terminated | 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. |
| Jun 20, 2005 | Z-1422-05 | — | terminated | 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. |
| Apr 13, 2005 | Z-1419-05 | — | terminated | Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent. |
| Mar 5, 2003 | Z-0899-03 | — | terminated | With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury. |
| Dec 20, 2002 | Z-1081-04 | — | terminated | Incorrect assay ranges on the assay value insert for Heparin Control 5. |
| Dec 4, 2002 | Z-1080-04 | — | terminated | The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Diagnostica Stago, Inc. PARSIPPANY, NJ · US FEI 2245451