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Health Canada Medical devices

Histocore Pegasus

Issued November 28, 2023
Issue
Leica Biosystems became aware, through post market surveillance, of an issue regarding poorly processed and/or damaged biopsy tissue specimens on the Histocore Pegasus / Histocore Pegasus Plus, resulting from incorrect assignment of the carryover value set for created or edited protocols. If the setup of carryover is lower than the actual carryover, it may potentially cause tissue damage (mainly under-processed tissue). Recall start date: November 9, 2023
Hazard description
Performance
Product
Product name
Histocore Pegasus
Reference
ID
RA-74662