Ventana CINtec p16 Histology 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 CINtec p16 Histology (250) kits that may cause false negative immunohistochemistry results because of leaking reagent dispensers. This could lead to incorrect test outcomes in medical diagnostics.

Why it’s dangerous

The reagent dispensers for horseradish peroxidase (HRP) can leak, causing false negative results in immunohistochemistry tests. This means the test might incorrectly show a negative result when the sample is actually positive.

Who’s affected

Pathologists and lab technicians using the CINtec p16 Histology kits for in vitro diagnostic testing. Those with lot numbers Y13547 or Y19158 are most at risk.

How to tell if you have this one

Check the lot number on the kit label. Affected lots are Y13547 and Y19158. The product is sold under catalog number 06695230001 with model 725-4713 for immunohistochemistry.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for lot numbers Y13547 or Y19158 on the product label.

✎ GovInfoNow

Questions people ask

What is the hazard with these kits?

Leaking reagent dispensers for horseradish peroxidase (HRP) can cause false negative immunohistochemistry results.

Which lots are affected?

Lot numbers Y13547 and Y19158.

Do I need to stop using these kits?

The recall does not specify a stop-use action; check the lot number to determine if you have an affected kit.

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-3012-2018 — Ventana Ventana

Hello,

I own a Ventana that is covered by recall Z-3012-2018 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-3012-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3012-2018 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 CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro

Lower-risk recall