Beckman Coulter has initiated a voluntary recall of 3,104 UniCel DxI 600 and 800 Access Immunoassay Analyzers. The recall was triggered by a software error where the system incorrectly resets motor current settings to a lower level than required during installation or upgrades. This mechanical issue can cause the system to experience movement errors, which may go unnoticed and lead to significant delays in reporting clinical test results for patient samples. No injuries or incidents have been reported in connection with this issue.
The software current setting error leads to increased mechanical motion errors in the system's gantries. These errors can cause the diagnostic instrument to stall or fail to process tests correctly, potentially delaying the delivery of critical laboratory results to healthcare providers and patients.
linear slide PnP gantries running software versions 5.7 and up
linear slide PnP gantries running software versions 5.7 and up
linear slide PnP gantries running software versions 5.7 and up
linear slide PnP gantries running software versions 5.7 and up
linear slide PnP gantries running software versions 5.7 and up
linear slide PnP gantries running software versions 5.7 and up
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.