Leica Biosystems Melbourne Pty Ltd: Device Recall
Recall #Z-1683-2025 · 04/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1683-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Leica Biosystems Melbourne Pty Ltd
- Status
- Ongoing
- Date Initiated
- 04/02/2025
- Location
- Mount Waverley, N/A, Australia
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 units
Reason for Recall
There is a leakage issue associated with the tubing in the manifold of the instrument.
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.
Distribution Pattern
US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.