FDA recall Z-2529-2024

Product

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.

Distribution

US Nationwide, including government distribution.

Key facts

Status

Ongoing

Initiation date

2024-05-10

Report date

2024-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nussloch, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2529-2024