Drug recall
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
FDA recall event 94776 · Class II · LEICA BIOSYSTEMS NUSSLOCH GMBH
Key facts
| Event ID | 94776 |
|---|---|
| Recall numbers | Z-2529-2024 |
| Recalling firm | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Product type | Devices |
| Products | Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank. |
| Initiation date | May 10, 2024 |
| Report date | Aug 14, 2024 |
| City | Nussloch |
| Country | Germany |
| FEI number | 3002179321 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: