Device recall: OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

Class I FDA enforcement event 78942. Recall start date: 19 Dec 2017. Status in the FDA record: Terminated. Termination date: 22 Nov 2021.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Ventana Medical Systems Inc started this device recall on 19 Dec 2017. The firm address in the FDA record is in Oro Valley, AZ. FDA put the recall in Class I. FDA event 78942 has 12 product records. The first FDA enforcement report date is 7 Mar 2018. The record gives the status Terminated, with the termination date 22 Nov 2021.

FDA enforcement report The 12 product records

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam,…

Recalling firm

Ventana Medical Systems Inc, Oro Valley, AZ.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

12 product records in the event.

FDA event 78942: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0729-2018	OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic	12028 units	Class I	Terminated	7 Mar 2018
Z-0730-2018	ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic	72730 units	Class I	Terminated	7 Mar 2018
Z-0731-2018	iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic	1980 units	Class I	Terminated	7 Mar 2018
Z-0732-2018	ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic	6 units	Class I	Terminated	7 Mar 2018
Z-0733-2018	ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic	20 units	Class I	Terminated	7 Mar 2018
Z-0734-2018	CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic	748 units	Class I	Terminated	7 Mar 2018
Z-0735-2018	CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic	18 units	Class I	Terminated	7 Mar 2018
Z-0736-2018	OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic	5040 units	Class I	Terminated	7 Mar 2018
Z-0737-2018	OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic	518 units	Class I	Terminated	7 Mar 2018
Z-0738-2018	Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic	71640 units	Class I	Terminated	7 Mar 2018
Z-0739-2018	ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic	358 units	Class I	Terminated	7 Mar 2018
Z-0740-2018	NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic	3122 units	Class I	Terminated	7 Mar 2018

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2017: 1,091
Share of these events in Class I: 3%
Product records in this event: 12Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Ventana Medical Systems Inc
Initiated	Product (first record)	Type	Class	Records
20 Apr 2026	navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Num	Device	Class II	1
27 Jun 2024	Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD	Device	Class II	1
18 Nov 2022	VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Pr	Device	Class II	1
1 Jun 2022	Ventana HE 600 System, automated slide preparer, for use in laboratories.	Device	Class II	1
20 Jan 2022	BenchMark ULTRA and DISCOVERY ULTRA Instruments	Device	Class II	1
4 Oct 2019	Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic p	Device	Class II	1
2 Aug 2018	OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagno	Device	Class I	21
28 Sep 2012	VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Onl	Device	Class II	2
12 Jun 2008	Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. P	Device	Class II	1

Ventana Medical Systems Inc: all 10 events

Official channels

FDA enforcement report Z-0729-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 78942. https://recallregister.com/fda/i/78942/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam,…
What quantity of product is in FDA event 78942?: The event has 12 product records. The first record gives this quantity: 12028 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 3% of the 1,091 device events that started in 2017 are in Class I.