Ventana Medical Systems recalls

Ventana Medical Systems appears in 42 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI…
  FDA Device · Class II · 2026-08-19 · Ventana Medical Systems
• Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
  FDA Device · Class II · 2024-08-28 · Ventana Medical Systems
• VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 080085400…
  FDA Device · Class II · 2023-01-18 · Ventana Medical Systems
• Ventana HE 600 System, automated slide preparer, for use in laboratories
  FDA Device · Class II · 2022-07-20 · Ventana Medical Systems
• BenchMark ULTRA and DISCOVERY ULTRA Instruments
  FDA Device · Class II · 2022-04-13 · Ventana Medical Systems
• Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) labor…
  FDA Device · Class II · 2020-06-17 · Ventana Medical Systems
• ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemist…
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistoche…
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnos…
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vit…
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use
  FDA Device · Class I · 2018-09-26 · Ventana Medical Systems
• OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
  FDA Device · Class I · 2018-03-07 · Ventana Medical Systems
• 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…
  FDA Device · Class II · 2013-09-04 · Ventana Medical Systems
• VENTANA (a member of the Roche Group) BenchMark ULTRA
  FDA Device · Class II · 2013-08-14 · Ventana Medical Systems
• VENTANA (a member of the Roche Group) DISCOVERY ULTRA
  FDA Device · Class II · 2013-08-14 · Ventana Medical Systems