Class II

Medical Device Recall: 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 tis

Leica Biosystems Melbourne Pty Ltd · April 2, 2025

Reason for Recall

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

Product Description

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.

Distribution

US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.

States Affected

AZ, CA, FL, MN, NC, NJ, NY, OH, PA, TN, TX, UT, VA, WI

Quantity Affected

77 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1683-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.