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Ventana Medical Systems

Last updated May 23, 2026

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Country: US
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Catalogue (812)

Page 14 of 17

Device	Model / Reference	Registries	Class	Status
BenchMark ULTRA	110v	FDA UDI	Class I	Unknown
VENTANA HER2 Dual ISH DNA Probe Cocktail	08314365001	FDA UDI	Class III	Active
Reag.Disp.Card, Prep Kit 87, 250-Series Test	05257581001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 72, BenchMark	05253918001	FDA UDI	Class I	Active
CONFIRM bcl-2 [124] Mouse Monoclonal Primary Antibody	05986826001	FDA UDI	Class I	Active
NexES Dispenser Card Option 4	05271878001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 93, 250-Series Test	05257646001	FDA UDI	Class I	Active
VENTANA HE 600 Organic Solution	07095163001	FDA UDI	Class I	Active
Endogenous Biotin Blocking Kit	05266092001	FDA UDI	Class I	Active
VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody	790-5091	FDA UDI	Class III	Active
Prep Kit	05250935001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 8 [25]	06457606001	FDA UDI	Class I	Active
VENTANA Protease Negative Reagent Control	08129088001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 546	09501231001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 2, BenchMark	05251338001	FDA UDI	Class I	Active
CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody	05278350001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 128, 250-Series Test	05258049001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 132, BenchMar	05252776001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 47, 250-Series Test	05257140001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 59, 250-Series Test	05257280001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 3, 250-Series Test	05256666001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 7, 250-Series Test	05256712001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 90, BenchMark	05254116001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 215	07678894001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 3 [25]	06457541001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 536	09501126001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 116, 250-Series Test	05257905001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 27, 250-Series Test	05256933001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 94, BenchMark	05252369001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Rna Ish Probe 2	07911343001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 13, BenchMark	05251460001	FDA UDI	Class I	Active
NexES Dispenser Card Fixative 3	05271649001	FDA UDI	Class I	Active
Confirm anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody	05986818001	FDA UDI	Class I	Active
anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody	06521924001	FDA UDI	Class I	Active
Reaction Buffer Concentrate (10X)	05353955001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 5 [25]	06457550001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 8, BenchMark	05251419001	FDA UDI	Class I	Active
BenchMark Special Stains Cleaning Kit	09476580001	FDA UDI	Class I	Active
Inline User Fillable Kit	05250927001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Rna Ish Probe 10	07911530001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 218	07678924001	FDA UDI	Class I	Active
BenchMark ULTRA PLUS Instrument	09576797001	FDA UDI	Class I	Active
CONFIRM CD8 [SP57] RabbitMono(Rabbit Monoclonal Primary Antibody	05937248001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 124, BenchMar	05252695001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 51, 250-Series Test	05257182001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 102, BenchMar	05252440001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 78, BenchMark	05253985001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 49, 250-Series Test	05257166001	FDA UDI	Class I	Active
Special Stains Van Gieson CS	09185992001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 137, 250-Series Test	05258138001	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.