Beckman Coulter is recalling 183 DxI 9000 Access Immunoassay Analyzers with software versions 1.17.0 and below. When these analyzers are connected to a laboratory automation system (LAS), a software defect prevents the analyzer from telling the automation system that its sample wheel is full. This causes the system to keep sending patient samples that cannot be processed, leading to samples being set aside or delayed. This issue is identified by a 'sample wheel timeout' (SWT) error flag on the test results and can occur at laboratories in the U.S. and 24 other countries.
The software failure leads to a backlog of patient samples that are not processed in time, resulting in delayed test results. These delays can directly lead to a delay in patient diagnosis and treatment, potentially worsening a patient's medical condition.
Software update and technical guidance
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.
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Sources: FDA iRES · Raw API Response
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