Class II
Medical Device Recall: Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
LEICA BIOSYSTEMS NUSSLOCH GMBH · May 10, 2024
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.
Distribution
US Nationwide, including government distribution.
States Affected
NATIONWIDE
Quantity Affected
180 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2529-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.