Public recall detail

HistoCore PELORIS 3

2025-08-27

medium
Recall Safety notice
Quick summary

Quick summary: HistoCore PELORIS 3. Date: 2025-08-27.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: HistoCore PELORIS 3. Date: 2025-08-27.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandLeica Biosystems Melbourne Pty Ltd.
ProductHistoCore PELORIS 3
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77993

Affected products

ProductHistoCore PELORIS 3
LotSN 45111072
Model45.0005
Serial numberSN 45111072
DescriptionHistoCore PELORIS 3
ProductHistoCore PELORIS 3
LotSN 45111184
Model45.0005
Serial numberSN 45111184
DescriptionHistoCore PELORIS 3
ProductHistoCore PELORIS 3
LotSN 45111172
Model45.0005
Serial numberSN 45111172
DescriptionHistoCore PELORIS 3
ProductHistoCore PELORIS 3
LotSN 45111153
Model45.0005
Serial numberSN 45111153
DescriptionHistoCore PELORIS 3

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

What you should do

  • Contact the manufacturer if you require additional information
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Pathology
CompaniesLeica Biosystems Melbourne Pty Ltd. 495 Blackburn Road, Mount Waverley, Victoria, Australia, 3149
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77993
Background{}
CompaniesLeica Biosystems Melbourne Pty Ltd. 495 Blackburn Road, Mount Waverley, Victoria, Australia, 3149
AudiencesHealthcare
Source updated2025-08-27

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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