Atlas FDA

Ventana Medical Systems, Inc.

55 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Ventana Medical Systems, Inc.

RecordFirmDate
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathol recall (Z-2913-2026)Ventana Medical Systems, Inc.2026-08-07
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD recall (Z-2644-2024)Ventana Medical Systems, Inc.2024-08-16
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA recall (Z-0907-2023)Ventana Medical Systems, Inc.2023-01-06
Ventana HE 600 System, automated slide preparer, for use in laboratories. recall (Z-1374-2022)Ventana Medical Systems Inc2022-07-12
BenchMark ULTRA and DISCOVERY ULTRA Instruments recall (Z-0894-2022)Ventana Medical Systems Inc2022-04-08
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemi recall (Z-2996-2018)Ventana Medical Systems Inc2018-09-14
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohis recall (Z-2997-2018)Ventana Medical Systems Inc2018-09-14
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (I recall (Z-2998-2018)Ventana Medical Systems Inc2018-09-14
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohisto recall (Z-2999-2018)Ventana Medical Systems Inc2018-09-14
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohis recall (Z-3000-2018)Ventana Medical Systems Inc2018-09-14
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. recall (Z-3001-2018)Ventana Medical Systems Inc2018-09-14
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistoch recall (Z-3002-2018)Ventana Medical Systems Inc2018-09-14
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immun recall (Z-3003-2018)Ventana Medical Systems Inc2018-09-14
ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, mo recall (Z-3004-2018)Ventana Medical Systems Inc2018-09-14
ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for recall (Z-3005-2018)Ventana Medical Systems Inc2018-09-14
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog recall (Z-3006-2018)Ventana Medical Systems Inc2018-09-14
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Numb recall (Z-3007-2018)Ventana Medical Systems Inc2018-09-14
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohist recall (Z-3008-2018)Ventana Medical Systems Inc2018-09-14
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immun recall (Z-3009-2018)Ventana Medical Systems Inc2018-09-14
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-101 recall (Z-3010-2018)Ventana Medical Systems Inc2018-09-14
CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (I recall (Z-3011-2018)Ventana Medical Systems Inc2018-09-14
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistr recall (Z-3012-2018)Ventana Medical Systems Inc2018-09-14
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemi recall (Z-3013-2018)Ventana Medical Systems Inc2018-09-14
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immuno recall (Z-3014-2018)Ventana Medical Systems Inc2018-09-14
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunoh recall (Z-3015-2018)Ventana Medical Systems Inc2018-09-14
ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistoche recall (Z-3016-2018)Ventana Medical Systems Inc2018-09-14
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vit recall (Z-0729-2018)Ventana Medical Systems Inc2018-02-27
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 recall (Z-0730-2018)Ventana Medical Systems Inc2018-02-27
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro recall (Z-0731-2018)Ventana Medical Systems Inc2018-02-27
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro recall (Z-0732-2018)Ventana Medical Systems Inc2018-02-27
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 i recall (Z-0733-2018)Ventana Medical Systems Inc2018-02-27
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in recall (Z-0734-2018)Ventana Medical Systems Inc2018-02-27
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 068895490 recall (Z-0735-2018)Ventana Medical Systems Inc2018-02-27
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro d recall (Z-0736-2018)Ventana Medical Systems Inc2018-02-27
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 recall (Z-0737-2018)Ventana Medical Systems Inc2018-02-27
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic recall (Z-0738-2018)Ventana Medical Systems Inc2018-02-27
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in v recall (Z-0739-2018)Ventana Medical Systems Inc2018-02-27
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084 recall (Z-0740-2018)Ventana Medical Systems Inc2018-02-27
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, recall (Z-2118-2013)Ventana Medical Systems Inc2013-08-28
VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only P recall (Z-0833-2013)Ventana Medical Systems Inc2013-08-06
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only P recall (Z-0834-2013)Ventana Medical Systems Inc2013-08-06
ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection k recall (Z-2716-2011)Ventana Medical Systems Inc2011-07-01
iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended recall (Z-2717-2011)Ventana Medical Systems Inc2011-07-01
VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5 recall (Z-1146-2010)Ventana Medical Systems Inc2010-03-16
Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with recall (Z-0571-2008)Ventana Medical Systems Inc2008-03-18
Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical recall (Z-0553-2008)Ventana Medical Systems Inc2008-01-25
Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc recall (Z-0537-2008)Ventana Medical Systems Inc2008-01-24
Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Ventana Medical System recall (Z-0538-2008)Ventana Medical Systems Inc2008-01-24
Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Ventana Medical System recall (Z-0539-2008)Ventana Medical Systems Inc2008-01-24
Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems Inc recall (Z-0540-2008)Ventana Medical Systems Inc2008-01-24
Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical System recall (Z-0541-2008)Ventana Medical Systems Inc2008-01-24
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-S recall (Z-0300-2008)Ventana Medical Systems Inc2008-01-09
CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939 recall (Z-0115-04)Ventana Medical Systems Inc2003-11-19
iVIEW DAB Detecion Kit. Catalog Number 760-091 recall (Z-0928-03)Ventana Medical Systems Inc2003-06-17
ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog recall (Z-0560-03)Ventana Medical Systems Inc2003-02-21

Track Ventana Medical Systems, Inc. automatically

Every clearance here is in the API, with alerts when new ones post.