Microbiologics Inc is recalling 28 units of Helix Elite Inactivated Standard (Inactivated Influenza A/B and Respiratory Syncytial Virus), a multi-analyte material used for laboratory quality control. The recall was initiated because the Respiratory Syncytial Virus (RSV) component may produce late results or fail to pass quality control checks. No incidents or injuries have been reported related to this issue.
The quality control material may fail to meet testing standards for RSV, which could lead to inaccurate validation of diagnostic tests and potentially unreliable patient results in clinical settings.
Recall #: Z-1454-2025; Quantity: 28 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.