Diasorin Inc. is recalling approximately 31,992 units of the LIAISON HSV-2 Type Specific IgG assay, a diagnostic test used to detect Herpes Simplex Virus Type 2. The recall was initiated because specific lots of the assay may produce an increased number of equivocal or false positive results. Consumers or patients who have recently undergone testing with this specific assay should be aware that their results may be inaccurate, leading to incorrect medical diagnoses.
The affected test kits may incorrectly indicate that a patient has HSV-2 (a false positive) or provide an uncertain result. This can lead to unnecessary psychological distress, improper treatment plans, or the failure to investigate other medical conditions.
Manufacturer Notification and Guidance
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.