Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HistoCore PELORIS 3 Recalled by Leica Biosystems Melbourne Pty Ltd Due to There is a leakage issue associated with the...

Date: April 2, 2025
Company: Leica Biosystems Melbourne Pty Ltd
Status: Ongoing
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 Leica Biosystems Melbourne Pty Ltd directly.

Affected Products

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

Quantity: 77 units

Why Was This Recalled?

There is a leakage issue associated with the tubing in the manifold of the instrument.

Where Was This Sold?

This product was distributed to 14 states: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, WI

Affected (14 states)Not affected

About Leica Biosystems Melbourne Pty Ltd

Leica Biosystems Melbourne Pty Ltd has 1 total recall tracked by RecallDetector.

Related Recalls

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