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Official recall record

Histocore Pegasus (ref 74662)

Health Canada — Medical Devices · 2023-11-28 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2023-11-28
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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