Beckman Coulter, Inc. is recalling 30 units of the DxI 9000 Access Immunoassay Analyzer (catalog number C11137) because ground screws on the internal circuit boards may cause electrical shorts. This defect can lead to smoke coming from the machine and potentially delay critical patient test results while the equipment is out of service. No injuries or incidents have been reported at this time.
An electrical short in the device can cause it to smoke, which poses a fire and safety hazard to laboratory staff and nearby equipment. Additionally, the resulting equipment failure can disrupt the processing of medical tests, leading to delays in patient diagnosis and treatment.
Quantity affected: 30 OUS (Outside US).
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.