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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 2 of 17

Device	Model / Reference	Registries	Class	Status
Assy Rgt Dspnr Card Bmk Prep Kit 240	09503994001	FDA UDI	Class I	Active
VENTANA CLDN18 (43-14A) RxDx Assay	08287066001	FDA UDI	Class II	Active
ultraView Red ISH DIG Detection Kit	100 tests	FDA UDI	Class I	Active
LCS (Predilute)	05264839001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 75, 250-Series Test	05257450001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Rna Ish Probe 5	07911378001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 239	09503951001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 116, BenchMar	05252601001	FDA UDI	Class I	Active
Jones Light Green Staining Kit	05279356001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 130, 250-Series Test	05258065001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 55, BenchMark	05253721001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 150, 250-Series Test	05258286001	FDA UDI	Class I	Active
VENTANA anti-EREG (SP326) Rabbit Monoclonal Primary Antibody	09858415001	FDA UDI	Class I	Active
CONFIRM Negative Control Rabbit Ig Antibody	05266238001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 16, BenchMark	05251494001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 110, 250-Series Test	05257832001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 59, BenchMark	05251966001	FDA UDI	Class I	Active
VENTANA DLL3 (SP347) Assay	08416931001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 213	07678878001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 504	05254264001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 98, 250-Series Test	05257719001	FDA UDI	Class I	Active
Protease 2	05266696001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 221	07678967001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 202	07678746001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 117, 250-Series Test	05257913001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 92, BenchMark	05254132001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 530	09501053001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 99, 250-Series Test	05257727001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 55, BenchMark	05251923001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 90, BenchMark	05252318001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 68, BenchMark	05253870001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 258	09504214001	FDA UDI	Class I	Active
NexES Dispenser Card Fixative 5	05271665001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 104, 250-Series Test	05257778001	FDA UDI	Class I	Active
CONFIRM anti-CD68 [KP-1] Primary Antibody	05278252001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 50, 250-Series Test	05257174001	FDA UDI	Class I	Active
NexES Dispenser Card Option 3	05271860001	FDA UDI	Class I	Active
Melanoma Triple Cocktail (HMB45+A103+T311) Primary Antibody	06527787001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 121, 250-Series Test	05257956001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 69, BenchMark	05253888001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 1 [25]	06457525001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 86, BenchMark	05254078001	FDA UDI	Class I	Active
CINtec PLUS Cytology	100 test	FDA UDI	N/A	Active
Cell Conditioning Solution (CC1)	05279801001	FDA UDI	Class I	Active
VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody	790-5095	FDA UDI	Class II	Active
CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody	05266904001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 113, BenchMar	05252571001	FDA UDI	Class I	Active
anti-p40 (BC28) Mouse Monoclonal Primary Antibody	07394420001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 11 [25]	06590357001	FDA UDI	Class I	Active
NexES Dispenser Card Counterstain 5	05271762001	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.