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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 (816)

Page 6 of 17

Device	Model / Reference	Registries	Class	Status
Assy Rgt Dspnr Card Bmk Prep Kit 251	09504141001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 543	09501207001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 207	07678819001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 4, 250-Series Test	05256674001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 51, BenchMark	05251885001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 83, BenchMark	05252245001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 89, BenchMark	05254108001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 97, BenchMark	05254191001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 254	09504176001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 129, BenchMar	05252741001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 96, BenchMark	05252385001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 54, BenchMark	05253713001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 92, 250-Series Test	05257638001	FDA UDI	Class I	Active
anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody	06640613001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 79, BenchMark	05252199001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 268	09504338001	FDA UDI	Class I	Active
CINtec Histology	50 Tests	FDA UDI	Class II	Active
Assy Rgt Dispenser Card Ish Probe 4 [25]	06457568001	FDA UDI	Class I	Active
FITC Anti-IGM Primary Antibody	05267935001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 126, BenchMar	05252717001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 39, BenchMark	05251753001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 49, BenchMark	05251869001	FDA UDI	Class I	Active
anti-EGFR E746-A750 del (SP111) Rabbit Monoclonal Primary Antibody	06521932001	FDA UDI	Class I	Active
VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary Antibody	790-5093	FDA UDI	Class III	Active
Reag.Disp.Card, Prep Kit 144, 250-Series Test	05258227001	FDA UDI	Class I	Active
Anti-CD44 (SP37) Rabbit Monoclonal Primary Antibody	06364985001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 509	05254337001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 235	09503862001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 25, BenchMark	05251591001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 87, BenchMark	05254086001	FDA UDI	Class I	Active
VENTANA PD-L1 (SP263) Assay	50 test	FDA UDI	Class III	Active
Hpv Family 6 System Control Slides [b]	05273528001	FDA UDI	Class I	Active
Steiner II Staining Kit	06521894001	FDA UDI	Class I	Active
anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody	06483186001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, BMK Prep Kit 502	05254248001	FDA UDI	Class I	Active
NexES Dispenser Card Counterstain 2	05271738001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 113, 250-Series Test	05257875001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 123, BenchMar	05252687001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 204	07678762001	FDA UDI	Class I	Active
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody	50 tests	FDA UDI	Class III	Active
CONFIRM anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody	05278422001	FDA UDI	Class I	Active
Assy Rgt Dispenser Card Bmk Prep Kit 216	07678908001	FDA UDI	Class I	Active
anti-p40 (SP225) Rabbit Monoclonal Primary Antibody	09929649001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 248	09504117001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 4, BenchMark	05251354001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 23, BenchMark	05251575001	FDA UDI	Class I	Active
ASSY, Reag.Disp.Card, PrepKit 142, BenchMar	05252881001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 243	09504052001	FDA UDI	Class I	Active
Assy Rgt Dspnr Card Bmk Prep Kit 253	09504168001	FDA UDI	Class I	Active
Reag.Disp.Card, Prep Kit 147, 250-Series Test	05258251001	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.