Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2024, with 41 FDA device recalls on record.
Top product codes for Ventana Medical Systems, Inc.
FDA recalls by Ventana Medical Systems, Inc.
10 most recent of 41- Z-2644-2024 — Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
- 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
- Z-1374-2022 — Ventana HE 600 System, automated slide preparer, for use in laboratories.
- Z-0894-2022 — BenchMark ULTRA and DISCOVERY ULTRA Instruments
- 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
- Z-3003-2018 — ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Z-3001-2018 — iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
- Z-3005-2018 — ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Z-3016-2018 — ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Z-2998-2018 — iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ventana Medical Systems, Inc.
- K242783 — Roche Digital Pathology Dx
- DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
- K232879 — Roche Digital Pathology Dx (VENTANA DP 200)
- K212176 — CINtec Histology
- K172471 — VENTANA CD30 (Ber-H2) RxDx Assay
- DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests)
- K142965 — Virtuoso System for IHC PR (1E2) using iScan HT
- K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
- K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI)
- K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
- K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
- K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
- K110215 — CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K121350 — VIRTUSO SYSTEM FOR IHC (DO-7)
- K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
- K111869 — VIRTUOSO SYSTEM FOR IHC PR (IE2)
- K111755 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
- K111543 — VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
- K101234 — VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K990618 — VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
- K940583 — VENTANA CD45 PRIMARY ANTIBODY
- K973389 — CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
- K973390 — CHEMMATE L26 (CD20)
- K973391 — CHEMMATE KAPPA
- K973392 — CHEMMATE LAMBDA
- K973393 — CHEMMATE LCA
- K941514 — VENTANA ANTI-S100 PRIMARY ANTIBODY
- K941170 — VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
- K941707 — ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
- K941604 — VENTANA ANTI-CD4 PRIMARY ANTIBODY
- K941784 — VENTANA ANTI-CD8 PRIMARY ANTIBODY
- K941397 — ANTI-VIMENTIN PRIMARY ANTIBODY
- K941516 — VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
- K940242 — VENTANA CEA PRIMARY ANTIBODY
- K941782 — VENTANA ANTI-CD5 PRIMARY ANTIBODY
- K941505 — VENTANNA ANTI-CD3 PRIMARY ANTIBODY
- K935161 — KERATIN PRIMARY ANTIBODY
- K941173 — ANTI-KERATIN-HMW PRIMARY ANTI-BODY
- K940331 — KERATIN PRIMARY ANTIBODY
- K940424 — VENTANA BLUE DETECTION KIT
- K940243 — VENTANA EMA PRIMARY ANDIBODY
- K931979 — VENTANA NEGATIVE CONTROL REAGENT
- K932386 — VENTANA RED DETECTION KIT
- K932326 — PSA ANTIBODY KIT
- K924578 — PSA ANTIBODY KIT
- K924629 — PAP ANTIBODY KIT
- K920600 — DAB DETECTION KIT
- K920566 — AEC DETECTION KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.