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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 3 of 17

Device	Model / Reference	Registries	Class	Status
Assy Rgt Dispenser Card Ish Probe 7 [25]	06457584001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 220	07678959001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 131, 250-Series Test	05258073001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 73, BenchMark	05252121001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 12, 250-Series Test	05256771001	FDA UDI	Class I	Active
CONFIRM® anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody	05266939001	FDA UDI	Class I	Active
Negative Control Monoclonal	05266670001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 97, BenchMark	05252393001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 62, BenchMark	05252008001	FDA UDI	Class I	Active
CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody	05552729001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 114, BenchMar	05252580001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 255	09504184001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 58, BenchMark	05253756001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 256	09504192001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 16, 250-Series Test	05256810001	FDA UDI	Class I	Active
anti-MLH-1 (M1) Mouse Monoclonal Primary Antibody	06472966001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 264	09504290001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 143, 250-Series Test	05258219001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 226	09503773001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 212	07678860001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 48, BenchMark	05251842001	FDA UDI	Class I	Active
VENTANA pan-TRK [EPR17341] Assay	08494665001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 89, 250-Series Test	05257603001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 544	09501215001	FDA UDI	Class I	Active
FITC Anti-Albumin Primary Antibody	05268087001	FDA UDI	Class I	Active
anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody	06504612001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Rna Ish Probe 8	07911432001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 18, 250-Series Test	05256836001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 72, 250-Series Test	05257425001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 88, BenchMark	05254094001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 140, 250-Series Test	05258162001	FDA UDI	Class I	Active
NexES Dispenser Card Fixative 1	05271614001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 273	09504397001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 39, 250-Series Test	05257069001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 100, BenchMar	05254221001	FDA UDI	Class I	Active
VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody	10384000001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 94, 250-Series Test	05257654001	FDA UDI	Class I	Active
Confirm anti-CD99 Mouse Monoclonal Primary Antibody	05913594001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 136, BenchMar	05252814001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 514	05254388001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 26, BenchMark	05251605001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 60, BenchMark	05251974001	FDA UDI	Class I	Active
ISH TSA Ancillary Kit	08507082001	FDA UDI	Class I	Active
NexES Dispenser Card Enzyme 3	05271533001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 62, 250-Series Test	05257310001	FDA UDI	Class I	Active
CONFIRM Anti-c-MET [SP44] Rabbit Monoclonal Primary Antibody	05571219001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 146, 250-Series Test	05258243001	FDA UDI	Class I	Active
Chromosome 12 DIG Probe ASR	06577059001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 80, 250-Series Test	05257506001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 43, 250-Series Test	05257107001	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.