Beckman Coulter, Inc. is recalling 324 units of the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137) running software version 1.20 due to a manufacturing defect. A motor/encoder and cable were installed incorrectly in specific units, causing the device to trigger error codes. This defect prevents the analyzer from performing medical tests (assays), leading to significant delays in generating patient results. No injuries have been reported, but field service is required to correct the installation and resolve the delays.
The incorrect motor installation causes instrument error codes that halt the diagnostic testing process. This results in a delay of laboratory results, which could potentially delay critical clinical diagnoses and patient treatment decisions.
Quantity: 324 units. Affects instruments manufactured starting with serial number 300141.
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.