Device recall: OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro…

Class I FDA enforcement event 80807. Recall start date: 2 Aug 2018. Status in the FDA record: Terminated. Termination date: 22 Nov 2021.

Reason for recall, in the words of FDA

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

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 2 Aug 2018. The firm address in the FDA record is in Oro Valley, AZ. FDA put the recall in Class I. FDA event 80807 has 21 product records. The first FDA enforcement report date is 26 Sep 2018. The record gives the status Terminated, with the termination date 22 Nov 2021.

FDA enforcement report The 21 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

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

21 product records in the event.

FDA event 80807: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2996-2018	OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.	11,712 units	Class I	Terminated	26 Sep 2018
Z-2997-2018	ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.	14,655 units	Class I	Terminated	26 Sep 2018
Z-2998-2018	iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.	3068 units	Class I	Terminated	26 Sep 2018
Z-2999-2018	ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.	96 units	Class I	Terminated	26 Sep 2018
Z-3000-2018	OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.	461 units	Class I	Terminated	26 Sep 2018
Z-3001-2018	iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.	10 units	Class I	Terminated	26 Sep 2018
Z-3002-2018	ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.	2136 units	Class I	Terminated	26 Sep 2018
Z-3003-2018	ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.	354 units	Class I	Terminated	26 Sep 2018
Z-3004-2018	ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.	8211 units	Class I	Terminated	26 Sep 2018
Z-3005-2018	ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.	2231 units	Class I	Terminated	26 Sep 2018
Z-3006-2018	CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.	1655 units	Class I	Terminated	26 Sep 2018
Z-3007-2018	CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.	1719 units	Class I	Terminated	26 Sep 2018
Z-3008-2018	VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.	559 units	Class I	Terminated	26 Sep 2018
Z-3009-2018	VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.	75 units	Class I	Terminated	26 Sep 2018
Z-3010-2018	VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.	2753 units	Class I	Terminated	26 Sep 2018
Z-3011-2018	CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.	120 units	Class I	Terminated	26 Sep 2018
Z-3012-2018	CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.	468 units	Class I	Terminated	26 Sep 2018
Z-3013-2018	CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.	240 units	Class I	Terminated	26 Sep 2018
Z-3014-2018	INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.	195 units	Class I	Terminated	26 Sep 2018
Z-3015-2018	NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.	2172 units	Class I	Terminated	26 Sep 2018
Z-3016-2018	ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.	342 units	Class I	Terminated	26 Sep 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 2018: 1,074
Share of these events in Class I: 4%
Product records in this event: 21Median 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
19 Dec 2017	OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic	Device	Class I	12
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-2996-2018The 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 80807. https://recallregister.com/fda/i/80807/. 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
What quantity of product is in FDA event 80807?: The event has 21 product records. The first record gives this quantity: 11,712 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 4% of the 1,074 device events that started in 2018 are in Class I.