Ventana ISH iView Blue Detection Kit Recall: 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 Medical Systems is recalling its ISH iView Blue Detection Kit (model 800-092) because reagent dispensers for horseradish peroxidase can leak and stick. This could lead to inaccurate test results or contamination in laboratory settings.

Why it’s dangerous

The reagent dispensers for horseradish peroxidase (HRP) can leak and stick, potentially causing inaccurate test results or contamination in laboratory procedures. This may affect the reliability of immunohistochemistry (IHC) tests.

Who’s affected

Laboratory users who purchased the ISH iView Blue Detection Kit with lot numbers Y15105 or Y22455 are affected. Pathologists and lab technicians using this kit for in vitro diagnostics are most at risk.

How to tell if you have this one

Check the lot number on the kit's packaging. Affected lots are Y15105 and Y22455. The product is model 800-092 for in vitro immunohistochemistry (IHC) diagnostics.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for lot numbers Y15105 or Y22455 on the kit's packaging to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Is there a fix for the leaking dispensers?

The recall record does not specify a remedy for the leaking dispensers.

What should I do if I have the affected kit?

The recall record does not specify any action steps for affected kits.

How can I tell if my kit is affected?

Check the lot number on the kit's packaging. Affected lots are Y15105 and Y22455.

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-3008-2018 — Ventana Ventana

Hello,

I own a Ventana that is covered by recall Z-3008-2018 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-3008-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3008-2018 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 VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro

Lower-risk recall