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Ventana Medical Systems

United States·US-MF-000016993

Last updated May 23, 2026

Information

Country: United States
Address: 1910, East Innovation Park Drive, Tucson, United States
Website: roche.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Susan Hollandbeck
EUDAMED SRN: US-MF-000016993
FDA FEI Number: —
DUNS Number: —

Catalogue (814)

Page 15 of 17

Device	Model / Reference	Registries	Class	Status
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
ASSY, Reag.Disp.Card, PrepKit 98, BenchMark	05254205001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 537	09501134001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 245	09504087001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 529	09501037001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 52, 250-Series Test	05257204001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 30, 250-Series Test	05256968001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 43, BenchMark	05251796001	FDA UDI	Class I	Active
NexES Dispenser Card Counterstain 4	05271754001	FDA UDI	Class I	Active
FITC anti-Lambda Primary Antibody	05267951001	FDA UDI	Class I	Active
iVIEW DAB Detection Kit	250 tests	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 225	07679009001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 44, 250-Series Test	05257115001	FDA UDI	Class I	Active
Protease 3	05266718001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 84, BenchMark	05252253001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 41, 250-Series Test	05257085001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 21, BenchMark	05251559001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 81, 250-Series Test	05257514001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 68, BenchMark	05252075001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 141, BenchMar	05252873001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 57, 250-Series Test	05257263001	FDA UDI	Class I	Active
Confirm anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody	05992184001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 6 [50]	06447384001	FDA UDI	Class I	Active
CINtec® p16 Histology	06695221001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 224	07678991001	FDA UDI	Class I	Active
Ventana Basal Cell Cocktail 34BE12+p63	06419445001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 9, BenchMark	05251427001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 103, BenchMar	05252458001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 517	05254418001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 88, 250-Series Test	05257590001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 24, BenchMark	05251583001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 33, 250-Series Test	05256992001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 77, 250-Series Test	05257476001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 512	05254361001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 54, BenchMark	05251915001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 3, BenchMark	05251346001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 208	07678827001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 266	09504311001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 14, BenchMark	05251478001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 95, BenchMark	05252377001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 112, 250-Series Test	05257867001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 82, BenchMark	05254035001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 11, BenchMark	05251443001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 42, 250-Series Test	05257093001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 206	07678797001	FDA UDI	Class I	Active
Light Protective Prep Kit	07475144001	FDA UDI	Class I	Active
Ish Protease 3	05273331001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 138, 250-Series Test	05258146001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Ish Probe 12 [25]	06590381001	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.