Ventana ultraView Universal DAB Kit Recall: False negatives from leaking reagent dispensers

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Ventana is recalling its ultraView Universal DAB Detection Kit (model 760-500) because leaking reagent dispensers can cause false negative results in immunohistochemistry tests. This could lead to incorrect test outcomes if the kit is used without proper maintenance.

Why it’s dangerous

The reagent dispensers in the kit can leak and stick, which may cause false negative results in immunohistochemistry (IHC) tests. This means the test might incorrectly show no disease presence when it actually exists.

Who’s affected

Pathologists and lab technicians using the ultraView Universal DAB Detection Kit for immunohistochemistry testing. Those with the specific lot numbers Y25695 or Y22147 are most at risk.

How to tell if you have this one

Check the product label for the model number 760-500 and catalog number 05269806001. Affected lots are Y25695 and Y22147.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the kit if it has the affected lot numbers Y25695 or Y22147.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The reagent dispensers can leak and stick, which may cause false negative results in immunohistochemistry tests.

What lot numbers are affected?

Lot numbers Y25695 and Y22147.

How do I know if I have the recalled kit?

Check the product label for model number 760-500 and catalog number 05269806001. Affected lots are Y25695 and Y22147.

Take action

Contact Ventana

We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2997-2018 — Ventana Ventana

Hello,

I own a Ventana that is covered by recall Z-2997-2018 from Ventana.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2997-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2997-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Ventana Medical Systems Inc recalls ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in

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