Lower risk Medical device recall · FDA · Published December 19, 2017

Ventana ultraView DAB Detection Kit: Leaking Reagent Risk

Ventana recalls ultraView Universal DAB Detection Kit (part 760-500) due to leaking and sticking reagent dispensers. Affected units have specific lot numbers and UDI codes. Stop using immediately to prevent potential contamination.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0730-2018Medical device Ventana ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmVentana Medical Systems Inc1910 E Innovation Park Dr · Oro Valley, AZ 85755-1962

✎ GovInfoNow plain-language explainer

Ventana is recalling its ultraView Universal DAB Detection Kit because reagent dispensers may leak or stick, especially with horseradish peroxidase and hematoxylin. This could lead to contamination in lab tests if not fixed. Read more at govinfonow.com/recall/72266-ventana-ultraview-dab-detection-kit-leaking-reagent-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72266-ventana-ultraview-dab-detection-kit-leaking-reagent-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0730-2018

Cite this page

“Ventana ultraView DAB Detection Kit: Leaking Reagent Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72266-ventana-ultraview-dab-detection-kit-leaking-reagent-risk. Based on FDA recall #Z-0730-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0730-2018%22&limit=1).

Ventana Medical Systems Inc. recalled the ultraView Universal DAB Detection Kit on Dec. 19, 2017, according to the FDA. The hazard involves leaking and sticking reagent dispensers.

How to tell if you have it

Brand: Ventana
Product: ultraView Universal DAB Detection Kit
Ventana part Number: 760-500
Roche GMMI: 05269806001
UDI: 04015630984039
Lot Numbers: Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147
Units: 72,730

The hazard

The recall addresses increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. This issue affects the iView, ultraView and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II.

Context

GovInfoNow's records show Ventana Medical Systems, Inc. has had 7 other recalls since Aug. 2, 2018. Other recent recalls include the Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall (April 20, 2026), the Ventana anti-CD10 antibody recall (June 27, 2024), and the Ventana PD-L1 (SP142) Assay Recall (Nov. 18, 2022). Other recent recalls of similar products include the Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026), the Illumina NextSeq 550Dx Reagent Kits recall (Oct. 28, 2025), and the Medline Blood Culture Kit Recall (Dec. 24, 2025).

How to tell if you have this one

Check for Ventana part number 760-500 and Roche GMMI 05269806001. Affected units have UDI 04015630984039 and specific lot numbers: Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147.

Brand
Ventana
Category
Medical device

FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

Recall number	Product, codes & lots	Quantity
Z-0729-2018	OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic; UDI 04015630984039, Lot Numbers: Y19271, Y11625, Y24225, Y15571	12028 units
Z-0730-2018	ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic; UDI 04015630984039, Lot Numbers: Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147	72730 units
Z-0731-2018	iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic; UDI 04015630971749, Lot Numbers: Y11834, Y24245	1980 units
Z-0732-2018	ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic; UDI 04015630972296, Lot Number: Y15133	6 units
Z-0733-2018	ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic; UDI 04015630970384, Lot Number: Y15146	20 units
Z-0734-2018	CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic; UDI 04015630972807, Lot Numbers: Y14122, Y18107	748 units
Z-0735-2018	CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic; UDI 04015630976287, Lot Numbers: Y22162, Y15546	18 units
Z-0736-2018	OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic; UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447	5040 units
Z-0737-2018	OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic; UDI 04015630984749, Lot Numbers: Y19318	518 units
Z-0738-2018	Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic; UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561	71640 units
Z-0739-2018	ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic; UDI 04015630972135, Lot Number: Y17990	358 units
Z-0740-2018	NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic; UDI 04015630970254, Lot Number: Y15392	3122 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for Ventana part number 760-500 and Roche GMMI 05269806001 on the kit.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.9 years after the firm started it.

Dec 19, 2017Firm started the recall
Mar 7, 2018Published in FDA’s Enforcement Report
Sep 14, 2018FDA classified it Class I
Nov 22, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72266-ventana-ultraview-dab-detection-kit-leaking-reagent-risk">Ventana ultraView DAB Detection Kit: Leaking Reagent Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0730-2018 (December 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0730-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.