Beckman Coulter, Inc. is recalling 19,125 Access Ultrasensitive Insulin reagent packs and 128 DxI 9000 Access Immunoassay Analyzers due to software and protocol file issues that can cause incorrect medical test results. The system may apply wrong conversion factors or incorrectly report results as '0' when they should show numerical values or symbols like '<' or '>'. These defects can affect multiple types of laboratory tests beyond insulin, potentially leading to incorrect medical diagnoses or treatment delays.
The software errors can cause the system to provide inaccurate patient test results, such as reporting a zero when the level is actually higher, or using an incorrect unit conversion for insulin levels. This poses a risk of incorrect clinical management of patients based on false laboratory data.
Software and protocol updates
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.