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Leica Biosystems Melbourne Pty Ltd recalls HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Ra

Recalled May 7, 2025 · FDA recall Z-1683-2025 · Leica Biosystems Melbourne Pty

Hazard
There is a leakage issue associated with the tubing in the manifold of the instrument. · FDA Class II
Units
77 units
Sold at
US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.

Description

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

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.
Manufacturer(s)
Leica Biosystems Melbourne Pty Ltd
Made in
Australia

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Leica Biosystems Melbourne Pty Ltd recalls HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Ra | RecallWatchUSA