HistoCore PELORIS 3 Rapid Tissue Processor Manifold 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 units were distributed across 14 US states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths. A leakage issue in laboratory equipment tubing represents a functional defect; without evidence of actual harm, it falls within the Moderate severity category for Class II medical device recalls.
Plain-English summary
Leica Biosystems Melbourne Pty Ltd is recalling 77 units of the HistoCore PELORIS 3 Rapid Tissue Processor (Model/Catalog Number 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 laboratory testing.
A leakage issue has been identified in the tubing of the instrument's manifold. The recalled units were distributed to clinical and laboratory facilities in Arizona, California, Florida, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Wisconsin.
Healthcare facilities and laboratories using affected serial numbers should contact Leica Biosystems for guidance on remediation. The FDA classification for this recall is Class II.
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
- leakage
- manifold-tubing
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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