FDA recall Z-1683-2025

Leica Biosystems Melbourne Pty Ltd · Class II · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-04-02
Report date: 2025-05-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mount Waverley, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2025