Recall MonitorHealth Products
HistoCore PELORIS 3
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Pathology
Product: HistoCore PELORIS 3
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information
Audience: Healthcare
Recall class: Type II
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