Device recall
Z-1683-2025: HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software…
FDA device recall · Class II · Leica Biosystems Melbourne Pty Ltd
Key facts
| Recall number (Z-number) | Z-1683-2025 |
|---|---|
| Recall event | 96612 |
| 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. |
| Product code | IEO |
| Recalling firm | Leica Biosystems Melbourne Pty Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3006461677 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database