Ventana ISH iVIEW Blue Plus Detection Kit Recall: False Negative IHC Results 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 its ISH iVIEW Blue Plus Detection Kit (model 760-097) 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 test results could be inaccurate, potentially leading to incorrect diagnoses.

Who’s affected

Pathologists and lab technicians using the ISH iVIEW Blue Plus Detection Kit for in vitro diagnostic tests are most at risk. The recall affects specific lot numbers Y15410 and Y24365.

How to tell if you have this one

Check the product label for model number 760-097 and catalog number 05266181001. Affected lots are Y15410 and Y24365.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for model number 760-097 and catalog number 05266181001 on the kit.

✎ GovInfoNow

Questions people ask

What is the hazard with this kit?

Leaking and sticking reagent dispensers can cause false negative results in immunohistochemistry (IHC) tests.

Which lots are affected?

Lots Y15410 and Y24365.

Is there a remedy for this recall?

The recall record does not specify a remedy.

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-3002-2018 — Ventana Ventana

Hello,

I own a Ventana that is covered by recall Z-3002-2018 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-3002-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3002-2018 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 ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro

Lower-risk recall