Chrysalis Intelligence · Sponsors · Ventana Medical Systems, Inc.

Ventana Medical Systems, Inc.

Tucson, AZ, US · 4 510(k) clearances · 130 PMAs · 4 recalls

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Total clearances
4
2021-12-10 → 2024-12-17
Last 12 months
0
Product codes
3
Most recent
2024-12-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PSY Whole Slide Imaging System Class II Pathology 2 2024-12-17
SDP Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit Class II Hematology 1 2024-12-05
PRB Cervical Intraepithelial Neoplasia (Cin) Test System Class II Pathology 1 2021-12-10
Class III

PMA approvals (130)

Total PMA records
130
Originals + supplements
Distinct product codes
10
First decision
2020-03-10
Most recent
2026-05-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-15 P990081-S058 PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Normal 180 Day Track MVC — —
2026-05-15 P190031-S015 HER2 Dual ISH DNA Probe Cocktail Normal 180 Day Track NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2026-01-06 P200019-S013 VENTANA anti-MSH6 (SP93) Antibody 30-Day Notice QNH — —
2025-12-15 P990081-S059 PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Normal 180 Day Track MVC — —
2025-12-15 P190031-S014 HER2 Dual ISH DNA Probe Cocktail Normal 180 Day Track NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2025-09-04 P190024-S015 CINtec PLUS Cytology 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2025-07-31 P190024-S014 CINtec PLUS Cytology Real-Time Process QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2025-06-20 P990081-S057 PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody 30-Day Notice MVC — —
2025-06-20 P230018-S001 VENTANA CLDN18 (43-14A) RxDx Assay 30-Day Notice QZJ Immunohistochemistry Assay, Antibody, Claudin 18 Hematology
2025-06-20 P220006-S007 VENTANA FOLR1 (FOLR-2.1) RxDx Assay 30-Day Notice QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2025-06-20 P200019-S012 VENTANA MMR RxDx Panel 30-Day Notice QNH — —
2025-06-20 P160046-S020 VENTANA PD-L1 (SP263) ASSAY 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2025-06-20 P140025-S025 VENTANA ALK (D5F3) CDX ASSAY 30-Day Notice PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2025-06-20 P020055-S032 PATHWAY® Anti-c-KIT (9.7) Primary Antibody 30-Day Notice NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2025-06-16 P190031-S013 VENTANA HER2 DualL ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2025-06-11 P990081-S056 PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Normal 180 Day Track MVC — —
2025-05-16 P190031-S012 VENTANA HER2 Dual ISH DNA Probe Cocktail Normal 180 Day Track NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2025-04-25 P190024-S013 CINtec PLUS Cytology Normal 180 Day Track QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2025-04-17 P200019-S011 VENTANA MMR RxDx Panel 30-Day Notice QNH — —
2025-03-12 P140025-S024 VENTANA ALK (D5F3) CDx Assay Normal 180 Day Track PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2025-01-27 P990081-S055 PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Panel Track MVC — —
2025-01-08 P220006-S006 VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Real-Time Process QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2024-12-20 P200019-S010 VENTANA MMR RxDx Panel Normal 180 Day Track QNH — —
2024-11-20 P990081-S054 PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Panel Track MVC — —
2024-10-23 P160046-S019 VENTANA PD-L1 (SP263) CDx Assay Normal 180 Day Track PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2024-10-18 P230018 VENTANA CLDN18 (43-14A) RxDx Assay Original QZJ Immunohistochemistry Assay, Antibody, Claudin 18 Hematology
2024-04-01 P160002-S024 VENTANA PD-L1(SP142) Assay 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2024-01-26 P990081-S053 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody Real-Time Process MVC — —
2024-01-26 P220006-S005 VENTANA FOLR1 (FOLR-2.1) RxDx Assay Real-Time Process QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2024-01-26 P200019-S009 VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) Real-Time Process QNH — —
2024-01-26 P190031-S010 VENTANA HER2 Dual ISH DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2024-01-26 P190024-S012 CINtec PLUS Cytology Real-Time Process QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2024-01-26 P160046-S018 VENTANA PD-Ll (SP263) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2024-01-26 P160002-S023 VENTANA PD-Ll (SP142) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2024-01-26 P140025-S023 VENTANA ALK (D5F3) CDx Assay Real-Time Process PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2024-01-26 P100027-S041 INFORM HER2 Dual ISH DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2024-01-26 P020055-S031 PATHWAY Anti-c-KIT (9.7) Primary Antibody Real-Time Process NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2023-11-08 P990081-S052 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody 30-Day Notice MVC — —
2023-11-08 P220006-S004 VENTANA FOLR1 (FOLR1-2.1) RxDx Assay 30-Day Notice QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2023-11-08 P200019-S008 VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM 30-Day Notice QNH — —
2023-11-08 P190031-S009 VENTANA HER2 Dual ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2023-11-08 P190024-S011 CINtec PLUS Cytology 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2023-11-08 P160046-S017 VENTANA PD-Ll (SP263) Assay 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2023-11-08 P160002-S022 VENTANA PD-Ll (SP142) Assay 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2023-11-08 P140025-S022 VENTANA ALK (D5F3) CDx Assay 30-Day Notice PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2023-11-08 P100027-S040 INFORM HER2 Dual ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2023-11-08 P020055-S030 PATHWAY Anti-c-KIT (9.7) Primary Antibody 30-Day Notice NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2023-08-29 P990081-S051 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody 30-Day Notice MVC — —
2023-08-29 P220006-S002 VENTANA FOLR1 (FOLR1-2.1) RxDx Assay 30-Day Notice QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2023-08-29 P200019-S007 VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) 30-Day Notice QNH — —
2023-08-29 P190031-S008 VENTANA HER2 Dual ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2023-08-29 P190024-S010 CINtec PLUS Cytology 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2023-08-29 P160046-S016 VENTANA PD-Ll (SP263) Assay 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2023-08-29 P160002-S021 VENTANA PD-Ll (SP142) Assay 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2023-08-29 P140025-S021 VENTANA ALK (D5F3) CDx Assay 30-Day Notice PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2023-08-29 P100027-S039 INFORM HER2 Dual ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2023-08-29 P020055-S029 PATHWAY Anti-c-KIT (9.7) Primary Antibody 30-Day Notice NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2023-08-23 P220006-S001 VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Normal 180 Day Track QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2023-03-01 P160046-S013 VENTANA PD-L1 (SP263) Assay Panel Track PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2023-02-07 P160002-S020 VENTANA PD-L1 (SP142) Assay Special (Immediate Track) PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2023-01-30 P190024-S009 CINtec PLUS Cytology 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2022-11-14 P220006 VENTANA FOLR1 (FOLR-2.1) RxDx Assay Original QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology
2022-11-10 P990081-S050 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody 30-Day Notice — — —
2022-11-10 P200019-S006 VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) 30-Day Notice QNH — —
2022-11-10 P190031-S007 VENTANA HER2 Dual ISH DNA Probe Cocktail 30-Day Notice — — —
2022-11-10 P190024-S008 CINtec PLUS Cytology 30-Day Notice — — —
2022-11-10 P160046-S015 VENTANA PD-L1 (SP263) Assay 30-Day Notice — — —
2022-11-10 P160002-S019 VENTANA PD-L1 (SP142) Assay 30-Day Notice — — —
2022-11-10 P140025-S020 VENTANA ALK (D5F3) CDx Assay 30-Day Notice — — —
2022-11-10 P100027-S038 INFORM HER2 Dual ISH DNA Probe Cocktail 30-Day Notice — — —
2022-11-10 P020055-S028 PATHWAY Anti-c-KIT (9.7) Primary Antibody 30-Day Notice NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2022-09-30 P990081-S047 PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Panel Track MVC — —
2022-07-29 P990081-S048 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody 30-Day Notice — — —
2022-07-29 P200019-S005 VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) 30-Day Notice QNH — —
2022-07-29 P190031-S005 VENTANA HER2 Dual ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2022-07-29 P190024-S007 CINtec PLUS Cytology 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2022-07-29 P160046-S014 VENTANA PD-L1 (SP263) Assay 30-Day Notice — — —
2022-07-29 P160002-S018 VENTANA PD-L1 (SP142) Assay 30-Day Notice — — —
2022-07-29 P140025-S018 VENTANA ALK (D5F3) CDx Assay 30-Day Notice PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2022-07-29 P100027-S037 INFORM HER2 Dual ISH DNA Probe Cocktail 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2022-07-29 P020055-S027 PATHWAY Anti-c-KIT (9.7) Primary Antibody 30-Day Notice NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2022-07-21 P990081-S046 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody Special (Immediate Track) MVC — —
2022-07-21 P200019-S004 VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) Special (Immediate Track) QNH — —
2022-07-21 P190031-S004 VENTANA HER2 Dual ISH DNA Probe Cocktail Special (Immediate Track) NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2022-07-21 P190024-S006 CINtec PLUS Cytology Special (Immediate Track) QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2022-07-21 P160046-S012 VENTANA PD-Ll (SP263) Assay Special (Immediate Track) PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2022-07-21 P160002-S017 VENTANA PD-Ll (SP142) Assay Special (Immediate Track) PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2022-07-21 P140025-S017 VENTANA ALK (D5F3) CDx Assay Special (Immediate Track) PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2022-07-21 P100027-S036 INFORM HER2 Dual ISH DNA Probe Cocktail Special (Immediate Track) NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2022-07-21 P020055-S026 PATHWAY Anti-c-KIT (9.7) Primary Antibody Special (Immediate Track) NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2022-06-10 P990081-S045 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody 135 Review Track For 30-Day Notice MVC — —
2022-06-10 P200019-S003 VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) 135 Review Track For 30-Day Notice QNH — —
2022-06-10 P190031-S003 VENTANA HER2 Dual ISH DNA Probe Cocktail 135 Review Track For 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2022-06-10 P190024-S005 CINtec PLUS Cytology 135 Review Track For 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2022-06-10 P160046-S011 VENTANA PD-L1 (SP263) Assay 135 Review Track For 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2022-06-10 P160002-S016 VENTANA PD-L1(SP142) Assay 135 Review Track For 30-Day Notice PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2022-06-10 P140025-S016 VENTANA ALK (D5F3) CDx Assay 135 Review Track For 30-Day Notice PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2022-06-10 P100027-S035 INFORM HER2 Dual ISH DNA Probe Cocktail 135 Review Track For 30-Day Notice NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2022-06-10 P020055-S025 PATHWAY Anti-c-KIT (9.7) Primary Antibody 135 Review Track For 30-Day Notice NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2021-10-15 P160046-S010 VENTANA PD-L1 (SP263) Assay Panel Track PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2021-09-28 P160002-S015 VENTANA PD-L1 (SP142) Assay Special (Immediate Track) PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2021-05-20 P990081-S044 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody Real-Time Process MVC — —
2021-05-20 P190031-S002 VENTANA HER2 Dual ISI-I DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2021-05-20 P190024-S003 CINtec PLUS Cytology Real-Time Process QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2021-05-20 P160046-S009 VENTANA PD-LI (SP263) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2021-05-20 P160002-S014 VENTANA PD-LI (SP142) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2021-05-20 P140025-S015 VENTANA ALK (D5F3) CDx Assay Real-Time Process PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2021-05-20 P100027-S034 INFORM HER2 Dual ISH DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2021-05-20 P020055-S024 PATI-IWAY Anti-c-KIT (9.7) Primary Antibody Real-Time Process NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2021-04-22 P200019 VENTANA MMR RxDx Panel Original QNH — —
2021-03-29 P190024-S004 CINtec PLUS Cytology 30-Day Notice QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2021-03-03 P140025-S014 VENTANA ALK (D5F3) CDx Assay Normal 180 Day Track PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2020-11-13 P990081-S043 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody Real-Time Process MVC — —
2020-11-13 P190031-S001 VENTANA HER2 Dual ISH DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2020-11-13 P190024-S002 CINtec PLUS Cytology Real-Time Process QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2020-11-13 P160046-S008 VENTANA PD-L1 (SP263) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2020-11-13 P160002-S013 VENTANA PD-L1 (SP142) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2020-11-13 P140025-S013 VENTANA ALK (D5F3) CDx Assay Real-Time Process PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2020-11-13 P100027-S033 INFORM HER2 Dual ISH DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2020-11-13 P020055-S023 PATHWAY Anti-c-KIT (9.7) Primary Antibody Real-Time Process NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2020-08-14 P190024-S001 CINtec PLUS Cytology Normal 180 Day Track QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
2020-07-28 P190031 HER2 Dual ISH DNA Probe Cocktail Original NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2020-05-18 P160002-S012 Ventana PD-L1 (SP142) Assay Normal 180 Day Track PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2020-03-31 P990081-S042 PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody Real-Time Process MVC — —
2020-03-31 P160046-S007 VENTANA PD-L1 (SP263) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2020-03-31 P160002-S011 VENTANA PD-L1(SP142) Assay Real-Time Process PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown
2020-03-31 P140025-S012 VENTANA ALK (D5F3) CDx Assay Real-Time Process PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown
2020-03-31 P100027-S032 INFORM HER2 Dual ISH DNA Probe Cocktail Real-Time Process NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown
2020-03-31 P020055-S022 PATHWAY Anti-c-KIT (9.7) Primary Antibody Real-Time Process NKF Immunohistochemistry Antibody Assay, C-Kit Hematology
2020-03-10 P190024 CINtec PLUS Cytology Original QKF Immunocytochemistry Assay, P16/Ki-67 Hematology
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-06-27
DateSeverityStatusRecall # ProductCodeReason
2024-06-27 Class II Ongoing 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.
2022-11-18 Class II Ongoing Z-0907-2023 VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IV… — Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause…
2022-06-01 Class II Ongoing 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
2022-01-20 Class II Ongoing 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 co…
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-12-17 K242783 Roche Digital Pathology Dx PSY Class II Pathology
2024-12-05 DEN240025 VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) SDP Class II Hematology
2024-06-14 K232879 Roche Digital Pathology Dx (VENTANA DP 200) PSY Class II Pathology
2021-12-10 K212176 CINtec Histology PRB Class II Pathology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence