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…
- Recall date
- April 2, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1683-2025
- FDA classification
- Class II
- Brand / firm
- Leica Biosystems Melbourne Pty Ltd
- Sold / distributed
- US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
Why it was recalled
There is a leakage issue associated with the tubing in the manifold of the instrument.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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