Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

INFORM HPV III Fam 16 Probe - US Export Recalled by Ventana Medical Systems Inc Due to Leaking and sticking reagent dispensers for horseradish peroxidase...

Date: August 2, 2018
Company: Ventana Medical Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ventana Medical Systems Inc directly.

Affected Products

INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.

Quantity: 195 units

Why Was This Recalled?

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Where Was This Sold?

worldwide

About Ventana Medical Systems Inc

Ventana Medical Systems Inc has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report