Beckman Coulter, Inc. is recalling 370 DxI 9000 Access Immunoassay Analyzers due to a software communication failure. When the analyzer is connected to a laboratory information system (LIS), it may lose communication if canceled quality control test results accumulate. No injuries or incidents have been reported. Laboratory personnel should contact the manufacturer or their distributor to arrange for a software update or correction.
A lost connection interrupts sample processing, which delays the reporting of patient test results. This delay can subsequently postpone critical patient treatment.
Affects all units running system software versions SW 1.20.0 and below.
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.