Ventana Medical Systems Inc
Tucson, AZ, US
VENTANA MEDICAL SYSTEMS, INC. appears in FDA device records in Tucson, AZ. FDA records list 49 510(k) clearances between and , 249 PMA records and one registered establishment. As of , FDA records show 56 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 49 510(k) clearances for Ventana Medical Systems Inc between 1992 and 2024. The busiest year on record is 1997, with 13. The most recent is 2024, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 6 |
| 1997 | 13 |
| 1999 | 1 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2021 | 1 |
| 2024 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242783 | Roche Digital Pathology Dx | PSY | Substantially Equivalent | |
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | SDP | Unknown | |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | PSY | Substantially Equivalent | |
| K212176 | CINtec Histology | PRB | Substantially Equivalent | |
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | DEH | Substantially Equivalent | |
| DEN170030 | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody | PZJ | Unknown | |
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | PRB | Unknown | |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | OEO | Substantially Equivalent | |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | NQN | Substantially Equivalent | |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | NQN | Substantially Equivalent | |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | NQN | Substantially Equivalent | |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | NQN | Substantially Equivalent | |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | NOT | Substantially Equivalent | |
| K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | MYA | Substantially Equivalent | |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | NOT | Substantially Equivalent | |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | NQN | Substantially Equivalent | |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | NQN | Substantially Equivalent | |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | NOT | Substantially Equivalent | |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | NOT | Substantially Equivalent | |
| K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY | OWF | Substantially Equivalent | |
| K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | MXZ | Substantially Equivalent | |
| K940583 | VENTANA CD45 PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K973392 | CHEMMATE LAMBDA | DEM | Substantially Equivalent | |
| K973391 | CHEMMATE KAPPA | DEM | Substantially Equivalent | |
| K973390 | CHEMMATE L26 (CD20) | DEM | Substantially Equivalent | |
| K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | DEM | Substantially Equivalent | |
| K973393 | CHEMMATE LCA | DEH | Substantially Equivalent | |
| K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941397 | ANTI-VIMENTIN PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K940242 | VENTANA CEA PRIMARY ANTIBODY | DFD | Substantially Equivalent | |
| K941782 | VENTANA ANTI-CD5 PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941505 | VENTANNA ANTI-CD3 PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K941173 | ANTI-KERATIN-HMW PRIMARY ANTI-BODY | DEH | Substantially Equivalent | |
| K935161 | KERATIN PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K940331 | KERATIN PRIMARY ANTIBODY | DEH | Substantially Equivalent | |
| K940424 | VENTANA BLUE DETECTION KIT | DEH | Substantially Equivalent | |
| K940243 | VENTANA EMA PRIMARY ANDIBODY | DHF | Substantially Equivalent | |
| K931979 | VENTANA NEGATIVE CONTROL REAGENT | DEM | Substantially Equivalent | |
| K932386 | VENTANA RED DETECTION KIT | DEY | Substantially Equivalent | |
| K932326 | PSA ANTIBODY KIT | DEH | Substantially Equivalent | |
| K924578 | PSA ANTIBODY KIT | DFD | Substantially Equivalent | |
| K924629 | PAP ANTIBODY KIT | DFD | Substantially Equivalent | |
| K920600 | DAB DETECTION KIT | DEY | Substantially Equivalent | |
| K920566 | AEC DETECTION KIT | DEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2028492 | 1000125183 | VENTANA MEDICAL SYSTEMS, INC. | 1910 EAST INNOVATION PARK DR., Tucson, AZ 85755 US | 2026 | and 45 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IDAAlcian Blue
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- ICZAmmoniacal Silver Hydroxide Silver Nitrate
- KFDAniline Blue
- OEOAutomated Digital Image Manual Interpretation Microscope
- ICLCarbol Fuchsin
- KIRCells, Animal And Human, Cultured
- PRBCervical Intraepithelial Neoplasia (Cin) Test System
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- ICHCongo Red
- KESCoverslips, Microscope Slide
- DHFD/Km-1, Antigen, Antiserum, Control
- IBCDiastase
- MAODna-Probe, Human Chromosome
- HYBEosin Y
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- HYFGiemsa Stain
- HYJHematoxylin
- DEYIgm, Peroxidase, Antigen, Antiserum, Control
- QKFImmunocytochemistry Assay, P16/Ki-67
- OWFImmunohistochemical Assay, Helicobacter Pylori
- NKFImmunohistochemistry Antibody Assay, C-Kit
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor
- PKWImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- QZJImmunohistochemistry Assay, Antibody, Claudin 18
- QULImmunohistochemistry Assay, Antibody, Folr1
- SERImmunohistochemistry Assay, Antibody, Met
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor
- PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- NJTImmunohistochemistry Reagents And Kits
- QNHImmunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
- HYIIodine, Grams
- GGHIron Stains
- SDPKappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
- DFDKappa, Peroxidase, Antigen, Antiserum, Control
- MAQKit, Dna Detection, Human Papillomavirus
- DEHLambda, Antigen, Antiserum, Control
- HYSLight Green
- PZJLynch Syndrome Test System
- HYZMethenamine Silver
- JRCMicro Pipette
- NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- NOTMicroscope, Automated, Image Analysis, Operator Intervention
- HZCMucicarmine
- HZFNuclear Fast Red
- JCCPh Buffer
- HZTReagent, Schiff
- MVUReagents, Specific, Analyte
- HZRResorcin Fuchsin
- KPASlide Stainer, Automated
- KEWSlides, Microscope
- KKPSolution, Silver Carbonate
- LEDStains, Chemical Solution
- JTSStains, Microbiologic
- MVCSystem, Test, Her-2/Neu, Ihc
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum
- IBGTrypsin
- IACVan Gieson'S Stain
- PSYWhole Slide Imaging System
Recall records
Showing 25 of 56| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2913-2026 | navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system. | Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window | Class II | Open, Classified | |
| Z-2644-2024 | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. | Class II | Open, Classified | |
| Z-0907-2023 | VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001 | Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result. | Class II | Open, Classified | |
| Z-1374-2022 | Ventana HE 600 System, automated slide preparer, for use in laboratories. | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire | Class II | Open, Classified | |
| Z-0894-2022 | BenchMark ULTRA and DISCOVERY ULTRA Instruments | Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire. | Class II | Open, Classified | |
| Z-2262-2020 | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in | The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components. | Class II | Completed | |
| Z-3016-2018 | ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3015-2018 | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3014-2018 | INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3013-2018 | CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3012-2018 | CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3011-2018 | CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3010-2018 | VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3009-2018 | VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3008-2018 | VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers | Class I | Terminated | |
| Z-3007-2018 | CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3006-2018 | CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3005-2018 | ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3004-2018 | ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3003-2018 | ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3002-2018 | ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3001-2018 | iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-3000-2018 | OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-2999-2018 | ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated | |
| Z-2998-2018 | iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain