Mount Waverley, Australia
Leica Biosystems Melbourne Pty Ltd recalls
1 recall recorded since 2018, most recently on 2 April 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 April 2025
- Reason
- There is a leakage issue associated with the tubing in the manifold of the instrument.
- Distribution
- US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1683-2025
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.