Immuno-Mycologics, Inc. (Immy) has recalled 30 vials of Candida ID Antigen (Lot F4171005) due to reduced sensitivity. This laboratory reagent is used in immunodiffusion tests to detect Candida fungal infections. A defect in the product may cause it to fail to detect the infection, resulting in a false negative result. No incidents or injuries have been reported to date.
A false negative result means a patient could be incorrectly told they do not have a Candida infection. This can lead to a significant delay in diagnosis and necessary medical treatment for a potentially serious fungal infection.
Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test; RX only; IVD; CE
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.