Microgenics Corporation has recalled approximately 4,462 units of Thermo Scientific MAS Omni CARDIO Liquid Assayed Integrated Cardiac Controls. These products are used in clinical laboratories to ensure the accuracy of cardiac tests. The recall was initiated because customers reported that the liquid inside different vials varied significantly, which can cause inconsistent results when testing for high-sensitivity Troponin I. This defect could lead to laboratory delays in delivering critical patient test results.
The variability between vials can cause errors or delays in cardiac test results. Such delays could postpone the diagnosis and treatment of serious heart conditions, such as a heart attack, where timely medical intervention is essential.
In Vitro Diagnostic external control
In Vitro Diagnostic external control
In Vitro Diagnostic external control
In Vitro Diagnostic external control
In Vitro Diagnostic external control
In Vitro Diagnostic external control
In Vitro Diagnostic external control
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.