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Histocore arcadia h
Official notice
8 May 2024
Last checked
8 May 2024
An official Health Canada notice concerns Histocore arcadia h. As part of the company's post market surveillance, they have identified an issue related to the safe usage of the HistoCore Arcadia H system. The problem is associated with the sealing of the paraffin tank. The process of paraffin solidification in the paraffin tank may lead to the deformation of the tank. This in turn, may cause the sealing of the tank to tear. Subsequent overfilling of the paraffin can cause the excess of melted paraffin to flow into the housing of the HistoCore Arcadia H. The paraffin can then soak into the insulation material. This may cause the saturated insulation material to fall onto the printed circuit board assembly and primary circuit. Because the paraffin-saturated insulation material no longer retains its flame resistance properties, this may lead to the development of toxic smoke and an internal fire in the HistoCore Arcadia H. Instruments manufactured after April 2017 do already have a reinforced tank which avoids any bending. Recall start date: May 2, 2024 Published 2024-05-08.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75498
Official notice
2024-05-08
The hazard
The hazard
As part of the company's post market surveillance, they have identified an issue related to the safe usage of the HistoCore Arcadia H system. The problem is associated with the sealing of the paraffin tank. The process of paraffin solidification in the paraffin tank may lead to the deformation of the tank. This in turn, may cause the sealing of the tank to tear. Subsequent overfilling of the paraffin can cause the excess of melted paraffin to flow into the housing of the HistoCore Arcadia H. The paraffin can then soak into the insulation material. This may cause the saturated insulation material to fall onto the printed circuit board assembly and primary circuit. Because the paraffin-saturated insulation material no longer retains its flame resistance properties, this may lead to the development of toxic smoke and an internal fire in the HistoCore Arcadia H. Instruments manufactured after April 2017 do already have a reinforced tank which avoids any bending. Recall start date: May 2, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Leica Biosystems Nussloch, Histocore Arcadia H.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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