VitalScientific
SEES Normandie, FR
VitalScientific appears in FDA device records in SEES Normandie, FR. FDA records list 11 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to VitalScientific carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- ELITech Clinical Systems SASenforcement report, recall
- ELITech Group B.V.enforcement report, recall
- Seppim S.A.S.510(k), enforcement report, recall
- Vital Scientific N.V.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 11 510(k) clearances for VitalScientific between 1998 and 2011. The busiest year on record is 2002, with 4. The most recent is 2011, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2002 | 4 |
| 2010 | 2 |
| 2011 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | JFY | Substantially Equivalent | |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | CDT | Substantially Equivalent | |
| K100547 | ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL | LCP | Substantially Equivalent | |
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | CEO | Substantially Equivalent | |
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 | CGA | Substantially Equivalent | |
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- | CIT | Substantially Equivalent | |
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | GFO | Substantially Equivalent | |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | KQG | Substantially Equivalent | |
| K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL | GGN | Substantially Equivalent | |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | GJS | Substantially Equivalent | |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | JJF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007662974 | 3007662974 | VitalScientific | Zone Industrielle, SEES Normandie 61500 FR | 2026 | and 27 more, listed in full below |
| 8030478 | 3001576181 | VitalScientific B.V. | VAN RENSSELAERWEG 4, SPANKEREN Gelderland 6956 AV NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- GFOActivated Partial Thromboplastin
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- CIGDiazo Colorimetry, Bilirubin
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JJPElectrode, Ion Selective (Non-Specified)
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- PPMGeneral Purpose Reagent
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- KQGInstrument, Coagulation
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- GGNPlasma, Coagulation Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- MRRSystem, Test, Low Density, Lipoprotein
- GJSTest, Time, Prothrombin
- JHWU.V. Method, Cpk Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0547-2020 | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 | During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report. | Class II | Open, Classified | |
| Z-0038-2020 | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring. | The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification. | Class II | Terminated | |
| Z-2591-2018 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 | ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced. | Class II | Terminated | |
| Z-2764-2019 | Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes. | Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. | Class III | Terminated | |
| Z-2558-2019 | V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring. | Instrument stopped working due to a software lockup, and no patient results are produced. | Class II | Open, Classified | |
| Z-0217-2016 | Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT | ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received. | Class II | Terminated | |
| Z-0216-2016 | ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G | ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received. | Class II | Terminated | |
| Z-0215-2016 | Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL) | ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received. | Class II | Terminated | |
| Z-0214-2016 | Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL) | ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received. | Class II | Terminated | |
| Z-0006-2015 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. | Class III | Terminated | |
| Z-0178-2014 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting. | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. | Class II | Terminated | |
| Z-0158-2020 | Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. | Class II | Terminated | |
| Z-0157-2020 | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. | Class II | Terminated | |
| Z-0156-2020 | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. | Class II | Terminated | |
| Z-0155-2020 | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. | Class II | Terminated | |
| Z-0154-2020 | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain