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Ventana Medical Systems

Last updated May 23, 2026

Information

Country: US
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Catalogue (812)

Page 1 of 17

Device	Model / Reference	Registries	Class	Status
Reag.Disp.Card, Prep Kit 125, 250-Series Test	05258006001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 84, BenchMark	05254051001	FDA UDI	Class I	Active
NexES Dispenser Card Fixative 4	05271657001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 533	09501088001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 71, BenchMark	05253900001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 62, BenchMark	05253802001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 66, BenchMark	05252059001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 76, BenchMark	05253969001	FDA UDI	Class I	Active
CONFIRM Anti-Vimentin [V9] Primary Antibody	05278139001	FDA UDI	Class I	Active
VENTANA MSLN (SP74) Assay	08508011001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 89, BenchMark	05252300001	FDA UDI	Class I	Active
CONFIRM Anti-P53 [DO-7] Primary Antibody	05278775001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 265	09504303001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 132, 250-Series Test	05258081001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 99, BenchMark	05252415001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 133, 250-Series Test	05258090001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 227	09503781001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 114, 250-Series Test	05257883001	FDA UDI	Class I	Active
Anti-CD43 (L60) Mouse Monoclonal Primary Antibody	05266980001	FDA UDI	Class I	Active
CONFIRM Anti-CD4 [SP35] Rabbit Monoclonal Primary Antibody	05552737001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 99, BenchMark	05254213001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 105, 250-Series Test	05257786001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 66, BenchMark	05253853001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 66, 250-Series Test	05257352001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 139, BenchMar	05252857001	FDA UDI	Class I	Active
Ventana Pdl1 Sp142 Assay	50tests	FDA UDI	Class III	Active
Reag.Disp.Card, Prep Kit 6, 250-Series Test	05256704001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 95, 250-Series Test	05257662001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 96, BenchMark	05254183001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 135, 250-Series Test	05258111001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 542	09501193001	FDA UDI	Class I	Active
VENTANA HE 600 Wash	06544312001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 136, 250-Series Test	05258120001	FDA UDI	Class I	Active
Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody	05267145001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 40, 250-Series Test	05257077001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 111, BenchMar	05252555001	FDA UDI	Class I	Active
Gram Staining Kit	06890105001	FDA UDI	Class I	Active
Ultraview Universal Ap Red Detection Kit	05269814001	FDA UDI	Class I	Active
CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody	05587760001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 32, 250-Series Test	05256984001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 67, 250-Series Test	05257379001	FDA UDI	Class I	Active
CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody	250 tests	FDA UDI	Class II	Active
Reag.Disp.Card, Prep Kit 71, 250-Series Test	05257417001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 128, BenchMar	05252733001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 1 [50]	06447325001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 104, BenchMar	05252466001	FDA UDI	Class I	Active
NexES Dispenser Card Option 1	05271843001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 92, BenchMark	05252334001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 53, 250-Series Test	05257212001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 42, BenchMark	05251788001	FDA UDI	Class I	Active

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FDA Recalls (55)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 27, 2024	Z-2644-2024	—	open, classified	Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Nov 18, 2022	Z-0907-2023	—	open, classified	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.
Jun 1, 2022	Z-1374-2022	—	open, classified	There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Jan 20, 2022	Z-0894-2022	—	open, classified	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.
Oct 4, 2019	Z-2262-2020	—	completed	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 and result in burned components.
Aug 2, 2018	Z-3011-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3016-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-2998-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3008-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
Aug 2, 2018	Z-3009-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-2997-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3004-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3012-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3014-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3006-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-2996-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3007-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3000-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3013-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3015-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3003-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3002-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3010-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3005-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-2999-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Aug 2, 2018	Z-3001-2018	—	terminated	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Dec 19, 2017	Z-0732-2018	—	terminated	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.
Dec 19, 2017	Z-0735-2018	—	terminated	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.
Dec 19, 2017	Z-0738-2018	—	terminated	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.
Dec 19, 2017	Z-0734-2018	—	terminated	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.
Dec 19, 2017	Z-0736-2018	—	terminated	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.
Dec 19, 2017	Z-0733-2018	—	terminated	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.
Dec 19, 2017	Z-0737-2018	—	terminated	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.
Dec 19, 2017	Z-0731-2018	—	terminated	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.
Dec 19, 2017	Z-0740-2018	—	terminated	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.
Dec 19, 2017	Z-0739-2018	—	terminated	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.
Dec 19, 2017	Z-0729-2018	—	terminated	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.
Dec 19, 2017	Z-0730-2018	—	terminated	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.
Sep 28, 2012	Z-0833-2013	—	terminated	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. This may create shorting conditions and u
Sep 28, 2012	Z-0834-2013	—	terminated	Potential 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.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu
May 16, 2011	Z-2717-2011	—	terminated	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 760-500, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number 760-091, lot B01057A.)
May 16, 2011	Z-2716-2011	—	terminated	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 760-500, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number 760-091, lot B01057A.)
Sep 17, 2009	Z-1146-2010	—	terminated	Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.
Jun 12, 2008	Z-2118-2013	—	terminated	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 message for the slide position.
Oct 30, 2007	Z-0553-2008	—	terminated	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.
Sep 6, 2007	Z-0300-2008	—	terminated	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.
Jun 26, 2007	Z-0571-2008	—	terminated	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.
Sep 29, 2006	Z-0538-2008	—	terminated	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.
Sep 29, 2006	Z-0537-2008	—	terminated	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.
Sep 29, 2006	Z-0541-2008	—	terminated	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.
Sep 29, 2006	Z-0540-2008	—	terminated	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.
Sep 29, 2006	Z-0539-2008	—	terminated	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.
May 7, 2003	Z-0928-03	—	terminated	Kit does not stain tissues properly.
Apr 4, 2003	Z-0115-04	—	terminated	Increased level of non-specific or background staining.
Oct 7, 2002	Z-0560-03	—	terminated	Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.