Leica Biosystems Melbourne Pty Ltd is recalling 77 HistoCore PELORIS 3 Rapid Tissue Processors (Model 45.0005/45.7512.501 A11, Software Version 3.4.0) due to a leakage issue with the tubing in the instrument manifold. These devices are used in laboratories to prepare patient tissue samples for diagnostic testing. A leak in the manifold can cause the processor to fail, potentially leading to damaged samples or significant delays in diagnostic results. No injuries or incidents have been reported at this time. These units were distributed across several states through authorized medical distributors.
The manifold tubing inside the tissue processor may leak, causing the instrument to malfunction. This failure can lead to the loss or improper processing of patient tissue samples, which may delay clinical diagnosis and subsequent medical treatment.
Quantity affected: 77 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.