Beckman Coulter, Inc. is recalling 731 DxC 500i and DxI 9000 Access Immunoassay Analyzers due to a software anomaly. This software error can prevent the systems from correctly applying manual dilution settings when laboratory staff order additional tests for a sample that is already being processed. This failure can result in the analyzer reporting incorrect patient data—either false high or false low results—and may cause significant delays in medical reporting.
The software error poses a risk of erroneous medical diagnoses and improper patient management because clinical results may be inaccurate. If undetected by laboratory staff, these incorrect results could lead to inappropriate medical treatments or delayed care for patients.
Recall #: Z-0215-2026. Quantity: 160 units.
Recall #: Z-0216-2026. Quantity: 571 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.
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
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