HistoCore PELORIS 3 Tissue Processor Recalled for Tubing Leakage
Leica Biosystems is recalling 77 units of the HistoCore PELORIS 3 rapid tissue processor due to a leakage issue in the manifold tubing. The affected devices were distributed across 14 US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with a known defect in critical tubing, presenting a risk-of-harm to laboratory operations and sample integrity. No illnesses, injuries, or hospitalizations have been reported in connection with the defect, placing it within the High category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Leica Biosystems Melbourne Pty Ltd is recalling the HistoCore PELORIS 3 Rapid Tissue Processor (Model 45.0005/45.7512.501 A11, Software Version 3.4.0). The device is a dual retort rapid tissue processor used to prepare tissue samples for pathology and medical research.
The recall affects 77 units distributed across 14 US states: Arizona, California, Florida, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Wisconsin. A leakage issue has been identified in the tubing of the instrument's manifold.
Facilities with affected units should verify their device's serial number and contact Leica Biosystems Melbourne Pty Ltd for guidance regarding corrective actions.
The recalled product
- Product
- HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
- Manufacturer
- Leica Biosystems Melbourne Pty Ltd
- Hazard
- tubing-leakage
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 09349458004811
- Serial Numbers: 45111117
- 45111154
- 45111155
- 45111156
- 45111157
- 45111158
- 45111159
- 45111160
- 45111161
- 45111162
- 45111164
- 45111166
- 45111167
- 45111168
- 45111169
- 45111170
- 45111171
- 45111174
- 45111175
Distribution
Distributed in 14 states:
- AZ
- CA
- FL
- MN
- NC
- NJ
- NY
- OH
- PA
- TN
- TX
- UT
- VA
- WI
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