Ventana CINtec p16 Histology Recall: False Negative IHC Results Risk

Take action

Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Ventana is recalling its CINtec p16 Histology (250) immunohistochemistry kits because leaking reagent dispensers could cause false negative results. This means test results might be inaccurate, potentially leading to incorrect diagnoses.

Why it’s dangerous

The reagent dispensers for horseradish peroxidase (HRP) can leak, causing false negative results in immunohistochemistry tests. This may lead to inaccurate cancer diagnoses if the test is used for detecting p16 protein.

Who’s affected

Pathologists and lab technicians using the CINtec p16 Histology kits for in vitro diagnostics are most affected. The recall applies to specific lots produced in 2022.

How to tell if you have this one

Check the lot number on the kit label: Y16507 or Y23040. The product is sold under catalog number 06695256001 with model 825-4713 for in vitro diagnostic use.

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 Y16507 or Y23040 on the product label.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The reagent dispensers for horseradish peroxidase (HRP) can leak, causing false negative results in immunohistochemistry tests.

What should I do if I have this product?

Check the lot number on the kit label. If it's Y16507 or Y23040, contact Ventana for instructions.

Is there a risk of serious injury?

No, the hazard is limited to potential false negative test results, not physical injury.

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-3013-2018 — Ventana Ventana

Hello,

I own a Ventana that is covered by recall Z-3013-2018 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-3013-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3013-2018 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) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro

Lower-risk recall