Recall Z-1683-2025— Leica Biosystems Melbourne Pty Ltd
Class II · Ongoing
Class II FDA medical device recall by Leica Biosystems Melbourne Pty Ltd, initiated 2025-04-02. FDA's recall record names no specific 510(k) clearance for this event. 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: There is a leakage issue associated with the tubing in the manifold of the instrument..
- Recalling firm
- Leica Biosystems Melbourne Pty Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-02
- Firm location
- Mount Waverley, N/A, Australia
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.
Reason for recall
There is a leakage issue associated with the tubing in the manifold of the instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.