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Health Canada Medical devices

HistoCore PELORIS 3

Issued August 27, 2025
Issue
Leica Biosystems has become aware of a reagent leakage issue associated with a tubing connection to a manifold in a small number of the HistoCore PELORIS 3 instruments. Our investigation has identified that the root cause of the leakage is due to isolated instances of incorrectly assembled fittings on a batch of manifolds. Leakage may expose instrument operators and other laboratory personnel to toxic reagents and pose a slip hazard. In case of significant leakage, tissue processing may be impacted. Recall start date: August 15, 2025
Hazard description
Performance
Product
Product name
HistoCore PELORIS 3
Reference
ID
RA-77993