Data / Medical devices / United States / Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc.: FDA-registered device maker in Tucson, AZ, United States, 10 510(k) clearances and 14 PMA approvals
Ventana Medical Systems, Inc. is registered with the FDA (registration 2028492) in Tucson, AZ, United States. It lists 55 device types. The FDA files 10 510(k) clearances and 14 PMA approvals under its listings, the newest dated June 12, 2026. 19 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2028492
- FEI number
- 1000125183
- Address
- 1910 East Innovation Park DR., Tucson, AZ, United States, 85755
- Owner or operator
- Roche Diagnostics Operations Inc. (9039767)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- February 4, 2000
- Registered through
- 2027
- Brand names listed
- 10X SSC, A1CD, cobas c 503, ALK (D5F3), ASSY RGT DISPENSER CARD ISH PROBE, ATRX CM Rabbit Polyclonal Antibody, AVENIO MILLISECT System, Accelerator I 1 x 100ML, Acid Wash Solution and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alcian Blue | IDA | 1 | Manufacturer | accessdata.fda.gov |
| Ammoniacal Silver Hydroxide Silver Nitrate | ICZ | 1 | Manufacturer | accessdata.fda.gov |
| Aniline Blue | KFD | 1 | Manufacturer | accessdata.fda.gov |
| Automated Digital Image Manual Interpretation Microscope | OEO | 2 | Manufacturer | accessdata.fda.gov |
| Carbol Fuchsin | ICL | 1 | Manufacturer | accessdata.fda.gov |
| Cells, Animal And Human, Cultured | KIR | 1 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Cervical Intraepithelial Neoplasia (Cin) Test System | PRB | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | NYQ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Congo Red | ICH | 1 | Manufacturer | accessdata.fda.gov |
| Coverslips, Microscope Slide | KES | 1 | Specification developer | accessdata.fda.gov |
| Diastase | IBC | 1 | Manufacturer | accessdata.fda.gov |
| Dna-Probe, Human Chromosome | MAO | U | Manufacturer for export | accessdata.fda.gov |
| Eosin Y | HYB | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Giemsa Stain | HYF | 1 | Manufacturer | accessdata.fda.gov |
| Hematoxylin | HYJ | 1 | Manufacturer | accessdata.fda.gov |
| Immunocytochemistry Assay, P16/Ki-67 | QKF | 3 | Manufacturer | accessdata.fda.gov |
| Immunohistochemical Assay, Helicobacter Pylori | OWF | 1 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Antibody Assay, C-Kit | NKF | 3 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Antibody Assay, Estrogen Receptor | MYA | 2 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase | PKW | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Claudin 18 | QZJ | 3 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Folr1 | QUL | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Met | SER | 3 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Progesterone Receptor | MXZ | 2 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | PLS | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Immunohistochemistry Reagents And Kits | NJT | 1 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay | QNH | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Iodine, Grams | HYI | 1 | Manufacturer | accessdata.fda.gov |
| Iron Stains | GGH | 1 | Manufacturer | accessdata.fda.gov |
| Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit | SDP | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Dna Detection, Human Papillomavirus | MAQ | 3 | Manufacturer for export | accessdata.fda.gov |
| Light Green | HYS | 1 | Manufacturer | accessdata.fda.gov |
| Lynch Syndrome Test System | PZJ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Methenamine Silver | HYZ | 1 | Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | NQN | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Automated, Image Analysis, Operator Intervention | NOT | 2 | Manufacturer | accessdata.fda.gov |
| Mucicarmine | HZC | 1 | Manufacturer | accessdata.fda.gov |
| Nuclear Fast Red | HZF | 1 | Manufacturer | accessdata.fda.gov |
| Ph Buffer | JCC | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Schiff | HZT | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Resorcin Fuchsin | HZR | 1 | Manufacturer | accessdata.fda.gov |
| SHF | SHF | Manufacturer | accessdata.fda.gov | |
| Slide Stainer, Automated | KPA | 1 | Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Manufacturer | accessdata.fda.gov |
| Solution, Silver Carbonate | KKP | 1 | Manufacturer | accessdata.fda.gov |
| Stains, Chemical Solution | LED | 1 | Manufacturer | accessdata.fda.gov |
| Stains, Microbiologic | JTS | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Her-2/Neu, Ihc | MVC | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Trypsin | IBG | 1 | Manufacturer | accessdata.fda.gov |
| Van Gieson'S Stain | IAC | 1 | Manufacturer | accessdata.fda.gov |
| Whole Slide Imaging System | PSY | 2 | Specification developer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2024 | K242783 | Roche Digital Pathology Dx | PSY | Substantially Equivalent | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| December 5, 2024 | DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | SDP | Unknown | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| June 14, 2024 | K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | PSY | Substantially Equivalent | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| October 27, 2017 | 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 | Ventana Medical Systems | accessdata.fda.gov |
| March 4, 2017 | DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | PRB | Unknown | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| July 16, 2015 | K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | OEO | Substantially Equivalent | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| March 20, 2014 | K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | NQN | Substantially Equivalent | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| December 17, 2012 | K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | MYA | Substantially Equivalent | Ventana Medical Systems, Inc. | accessdata.fda.gov |
| November 16, 2011 | K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | MXZ | Substantially Equivalent | Ventana Medical Sytems, Inc. | accessdata.fda.gov |
| August 25, 2011 | K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY | OWF | Substantially Equivalent | Ventana Medical Systems, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | P250031 | VENTANA PTEN (SP218) RxDx Assay | SHF | 0 | June 12, 2026 | accessdata.fda.gov |
| May 14, 2025 | P240037 | VENTANA MET (SP44) RxDx Assay | SER | 3 | October 23, 2026 | accessdata.fda.gov |
| October 18, 2024 | P230018 | VENTANA CLDN18 (43-14A) RxDx Assay | QZJ | 1 | June 20, 2025 | accessdata.fda.gov |
| November 14, 2022 | P220006 | VENTANA FOLR1 (FOLR-2.1) RxDx Assay | QUL | 6 | June 20, 2025 | accessdata.fda.gov |
| August 17, 2021 | P210001 | VENTANA MMR RxDx Panel | QNH | 16 | October 8, 2026 | accessdata.fda.gov |
| April 22, 2021 | P200019 | VENTANA MMR RxDx Panel | QNH | 12 | October 8, 2026 | accessdata.fda.gov |
| July 28, 2020 | P190031 | HER2 Dual ISH DNA Probe Cocktail | NYQ | 14 | August 25, 2026 | accessdata.fda.gov |
| March 10, 2020 | P190024 | CINtec PLUS Cytology | QKF | 15 | September 4, 2025 | accessdata.fda.gov |
| May 1, 2017 | P160046 | VENTANA PD-L1 (SP263) ASSAY | PLS | 18 | June 20, 2025 | accessdata.fda.gov |
| May 18, 2016 | P160002 | VENTANA PD-L1(SP142) CDX ASSAY | PLS | 21 | April 1, 2024 | accessdata.fda.gov |
| June 12, 2015 | P140025 | VENTANA ALK (D5F3) CDX ASSAY | PKW | 23 | June 20, 2025 | accessdata.fda.gov |
| June 14, 2011 | P100027 | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL | NYQ | 40 | January 26, 2024 | accessdata.fda.gov |
| August 11, 2004 | P020055 | VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY | NKF | 31 | June 20, 2025 | accessdata.fda.gov |
| November 28, 2000 | P990081 | PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY | MVC | 57 | August 25, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2026 | 98998 | Class II | Ongoing | 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 | Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window | accessdata.fda.gov |
| June 27, 2024 | 94985 | Class II | Ongoing | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF:, 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. | accessdata.fda.gov |
| November 18, 2022 | 91199 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 1, 2022 | 90363 | Class II | Ongoing | 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 | accessdata.fda.gov |
| January 20, 2022 | 89727 | Class II | Ongoing | 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. | accessdata.fda.gov |
| October 4, 2019 | 85526 | Class II | Completed | 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 l | 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 an | accessdata.fda.gov |
| August 2, 2018 | 80807 | Class I | Terminated | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model Immunohistochemistry (IHC) for in vitro diagnostic use. | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. | accessdata.fda.gov |
| December 19, 2017 | 78942 | Class I | Terminated | OptiView DAB IHC Detection Kit, Ventana Part Number, Roche GMMI 06396500001 in vitro diagnostic | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | accessdata.fda.gov |
| September 28, 2012 | 64244 | Class II | Terminated | VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytologica | Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. T | accessdata.fda.gov |
| May 16, 2011 | 58855 | Not yet classified | Terminated | ultraView Universal DAB Detection Kit, Part number: (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number, lot B01057A.) | accessdata.fda.gov |
| September 17, 2009 | 53597 | Not yet classified | Terminated | VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number:, Lot number: 680957, in vitro diagnostic. | Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody. | accessdata.fda.gov |
| June 12, 2008 | 49516 | Class II | Terminated | Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or | Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error m | accessdata.fda.gov |
| October 30, 2007 | 45891 | Not yet classified | Terminated | Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc | Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement. | accessdata.fda.gov |
| September 6, 2007 | 45437 | Not yet classified | Terminated | Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ | Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists. | accessdata.fda.gov |
| June 26, 2007 | 45798 | Not yet classified | Terminated | Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, | Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system. | accessdata.fda.gov |
| September 29, 2006 | 45496 | Not yet classified | Terminated | Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc, Tucson, AZ | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. | accessdata.fda.gov |
| May 7, 2003 | 26321 | Not yet classified | Terminated | iVIEW DAB Detecion Kit. Catalog Number | Kit does not stain tissues properly. | accessdata.fda.gov |
| April 4, 2003 | 26070 | Not yet classified | Terminated | CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number | Increased level of non-specific or background staining. | accessdata.fda.gov |
| October 7, 2002 | 25425 | Not yet classified | Terminated | ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111. | Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail. | accessdata.fda.gov |
Compare with other makers
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- All makers of General Purpose Reagent
Updated August 7, 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.