Beckman Coulter, Inc. is recalling 61 units of the DxI 9000 Access Immunoassay Analyzer (catalog number C11137) due to a software error. The error causes mechanical issues with the instrument's tray gripper, leading to unexpected hard stops and significant delays in processing patient test results. No injuries or incidents have been reported, but the manufacturer initiated this voluntary recall to correct the software.
The software malfunction causes intermittent mechanical failures that stop the diagnostic process. This can result in delayed results for critical patient tests, which may interfere with timely medical decisions and patient care.
Quantity affected: 61 units.
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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