Recall Register

Ventana Medical Systems, Inc.: FDA recalls

FDA enforcement reports name Ventana Medical Systems, Inc. as the recalling firm in 10 events. The events have 42 product records. The recalls started from 2008 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

10 events, newest first.

FDA enforcement events of Ventana Medical Systems, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
20 Apr 2026navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx…DeviceClass II1Ongoing
27 Jun 2024Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDDeviceClass II1Ongoing
18 Nov 2022VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001DeviceClass II1Ongoing
1 Jun 2022Ventana HE 600 System, automated slide preparer, for use in laboratories.DeviceClass II1Ongoing
20 Jan 2022BenchMark ULTRA and DISCOVERY ULTRA InstrumentsDeviceClass II1Ongoing
4 Oct 2019Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users inDeviceClass II1Completed
2 Aug 2018OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.DeviceClass I21Terminated
19 Dec 2017OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnosticDeviceClass I12Terminated
28 Sep 2012VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ…DeviceClass II2Terminated
12 Jun 2008Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Ventana Medical Systems, Inc.: events for each product type
TypeEvents
Device10
Ventana Medical Systems, Inc.: events in each class
ClassEvents
Class II8
Class I2
Share of the events of the firm in Class I
20%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Ventana Medical Systems, Inc., by the year that the recall started. The largest year is 2022, with 3 events.

Official channels

Cite this page

Recall Register. Ventana Medical Systems, Inc.: FDA recalls. https://recallregister.com/firm/ventana-medical-systems-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
AZ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Ventana Medical Systems, Inc. have?
Class II: 8 events. Class I: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Ventana Medical Systems, Inc.?
FDA event 98998, which the firm started on 20 Apr 2026. The first product in the record is: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx…
How many FDA recalls of Ventana Medical Systems, Inc. have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.