FDA-Device2024-08-14Class II
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
LEICA BIOSYSTEMS NUSSLOCH GMBH
Hazard
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.
Sold states
US Nationwide, including government distribution.
Affected count
180 devices
Manufactured in
Heidelberger Str. 17-19, Nussloch, Germany
Products
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2024Don't want to check this manually?
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