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LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Recalled August 14, 2024 · FDA recall Z-2529-2024 · LEICA BIOSYSTEMS NUSSLOCH
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. · FDA Class II
Units
180 devices
Sold at
US Nationwide, including government distribution.
Description
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.
Product
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Manufacturer(s)
LEICA BIOSYSTEMS NUSSLOCH GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →