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Official recall record

HistoCore PELORIS 3 (ref 77993)

Health Canada — Medical Devices · 2025-08-27 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-08-27
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

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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