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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 4 of 17

Device	Model / Reference	Registries	Class	Status
HybReady Solution	05917557001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 230	09503811001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 12, BenchMark	05251451001	FDA UDI	Class I	Active
NexES Dispenser Card Enzyme 5	05271550001	FDA UDI	Class I	Active
NexES Dispenser Card Enzyme 4	05271541001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 142, 250-Series Test	05258197001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Rna Ish Probe 1	07911327001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 82, BenchMark	05252237001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 515	05254396001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 77, BenchMark	05253977001	FDA UDI	Class I	Active
Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody	09592237001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 26, 250-Series Test	05256925001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 85, 250-Series Test	05257565001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 274	09504419001	FDA UDI	Class I	Active
NexES Dispenser Card Option 8	05271916001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 50, BenchMark	05251877001	FDA UDI	Class I	Active
AFB III Staining Kit	05279437001	FDA UDI	Class I	Active
CONFIRM anti-Melanosome [HMB45] Mouse Monoclonal Primary Antibody	05479282001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 78, BenchMark	05252172001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 53, BenchMark	05253705001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 232	09503838001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 5 [50]	06447376001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 129, 250-Series Test	05258057001	FDA UDI	Class I	Active
VENTANA TFF3 (7F1.21) Mouse Monoclonal Primary Antibody	07712812001	FDA UDI	Class I	Active
CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody	05878900001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 1, 250-Series Test	05256640001	FDA UDI	Class I	Active
CONFIRM Anti-Epidermal Growth Factor Receptor (3C6) Primary Antibody	05278341001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 91, BenchMark	05254124001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 109, 250-Series Test	05257824001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 532	09501070001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 126, 250-Series Test	05258014001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 70, BenchMark	05252091001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 61, BenchMark	05251982001	FDA UDI	Class I	Active
CONFIRM anti-MSH6 [44] Mouse Monoclonal Primary Antibody	05929911001	FDA UDI	Class I	Active
OptiView Amplification Kit	06396518001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 20, 250-Series Test	05256852001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 241	09504036001	FDA UDI	Class I	Active
VENTANA HE 600 Bluing	06544347001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 270	09504354001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 122, BenchMar	05252679001	FDA UDI	Class I	Active
VENTANA anti-AREG (SP272) Rabbit Monoclonal Primary Antibody	09858725001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 83, 250-Series Test	05257549001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 32, BenchMark	05251664001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 79, BenchMark	05253993001	FDA UDI	Class I	Active
10x Ssc Solution	05353947001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 524	05254493001	FDA UDI	Class I	Active
NexES Dispenser Card Counterstain 1	05271720001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 252	09504150001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 34, 250-Series Test	05257000001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 93, BenchMark	05252342001	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.