Reported Aug 14, 2024 · Ongoing
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Leica Biosystems Nussloch GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEICA BIOSYSTEMS NUSSLOCH GMBH · Heidelberger Str. 17-19 · Nussloch · N/A
Is this the product you have?
- Leica HistoCore Arcadia H
- REF14039354100 and 14039357258, Paraffin Embedding Station
- Lot codes and dates
- Model/Catalog Number14039354100
- UDI-DI04049188194763
- Serial numbers
179 of 179 codes
58629899101117120121122123124125127128129177178179180181185186218222223279282284286287288289290291292314315317318319321322353354355356357358360363365366371478480483484487488489
- Model/Catalog Number14039357258
- UDI-DI
04049188205971serial number 5033
- Amount recalled
- 180 devices
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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