Recall Z-2529-2024— LEICA BIOSYSTEMS NUSSLOCH GMBH
Class II · Ongoing
Class II FDA medical device recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, initiated 2024-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.. Reason: 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..
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-10
- Firm location
- Nussloch, Germany
Product description
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.