Health product recall

HistoCore PELORIS 3

Last updated

Summary

Product
HistoCore PELORIS 3
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
HistoCore PELORIS 3 SN 45111072 45.0005
HistoCore PELORIS 3 SN 45111184 45.0005
HistoCore PELORIS 3 SN 45111172 45.0005
HistoCore PELORIS 3 SN 45111153 45.0005

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies

Leica Biosystems Melbourne Pty Ltd.

495 Blackburn Road, Mount Waverley, Victoria, Australia, 3149

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77993

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