Public recall detail

HistoCore PELORIS 3

2025-04-10

medium
Recall Safety notice
Quick summary

Quick summary: HistoCore PELORIS 3. Date: 2025-04-10.

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: 2025-04-10.

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-77259

Affected products

ProductHistoCore PELORIS 3
Lot45111184 45111172
Model45.0005
Serial number45111184 45111172
DescriptionHistoCore PELORIS 3

Issue

Leica Biosystems has become aware of a leakage issue associated with the tubing in the manifold of the HistoCore PELORIS 3 instrument. Leakage may expose instrument operators and other laboratory personnel to toxic chemicals and pose a slip hazard. Recall start date: April 2, 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-77259
Background{}
CompaniesLeica Biosystems Melbourne Pty Ltd. 495 Blackburn Road, Mount Waverley, Victoria, Australia, 3149
AudiencesHealthcare
Source updated2025-04-10

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

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