FDA-Device2025-05-07Class II
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.
Leica Biosystems Melbourne Pty Ltd
Hazard
There is a leakage issue associated with the tubing in the manifold of the instrument.
Sold states
US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
Affected count
77 units
Manufactured in
495 Blackburn Road, N/A, Mount Waverley, N/A, Australia
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2025Don't want to check this manually?
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