Biocartis Nv has recalled 8 Idylla Instruments (IVD, REF P0010) because they may generate false-positive "MSI-H" results during testing. A false-positive result incorrectly indicates the presence of a specific genetic marker, which could lead to inappropriate medical management. No injuries or incidents have been reported, and clinical laboratories or distributors should contact the manufacturer to arrange for a correction or replacement.
A false-positive test result may cause clinicians to make incorrect treatment or monitoring decisions for a patient based on inaccurate genetic data. This could result in patients receiving unnecessary therapies or failing to receive appropriate care.
Intended for the detection of nucleic acid targets in various types of human samples using disposable Test-specific Idylla Cartridges.
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.