Beckman Coulter, Inc. is recalling 245 units of the DxI 9000 Access Immunoassay Analyzer because the wash wheel mixer may fail to spin freely. This mechanical defect can trigger system errors that stop the analyzer from functioning, leading to cancelled tests and significant delays in reporting patient results. No injuries or incidents have been reported in connection with this issue.
A malfunctioning mixer component can cause the analyzer to enter an error state, which cancels tests currently in progress. This delay in diagnostic reporting could potentially impact timely patient care and treatment decisions.
Affects catalog number C11137 with serial numbers enumerated above.
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.