Ventana ultraView Universal Alkaline Phosphatase Kit Recall: False Negative Risk

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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 certain lots of their ultraView Universal Alkaline Phosphatase Red Detection Kit. This kit can cause false negative results in immunohistochemistry tests if the reagent dispensers leak or stick.

Why it’s dangerous

The reagent dispensers for horseradish peroxidase (HRP) can leak or stick, which may cause false negative results in immunohistochemistry (IHC) tests. This could lead to incorrect diagnoses if the test is used for medical purposes.

Who’s affected

Pathologists and lab technicians using the kit for immunohistochemistry tests. Those with the specific lot numbers Y15071, Y18053, or Y22469 are most at risk.

How to tell if you have this one

Check the lot number on the kit's packaging. The affected lots are Y15071, Y18053, and Y22469. The product is sold under the model 760-501 with catalog number 05269814001.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for the lot number on the product packaging to determine if it is affected (Y15071, Y18053, or Y22469).

✎ GovInfoNow

Questions people ask

What is the specific model of the recalled kit?

The recalled kit is the ultraView Universal Alkaline Phosphatase Red Detection Kit, model 760-501 with catalog number 05269814001.

What lot numbers are affected?

The affected lot numbers are Y15071, Y18053, and Y22469.

What is the hazard with this kit?

The reagent dispensers for horseradish peroxidase (HRP) can leak or stick, which may cause false negative results in immunohistochemistry (IHC) tests.

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-3004-2018 — Ventana Ventana

Hello,

I own a Ventana that is covered by recall Z-3004-2018 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-3004-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3004-2018 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 Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501

Lower-risk recall