Beckman Coulter Inc. is recalling approximately 116 units of the DxC 500i Clinical Analyzer (including modules with and without Ion-Selective Electrode functionality). The recall is due to a software issue that occurs when Clinical Chemistry and Immunoassay tests are ordered at the same time. If the Immunoassay test is processed in the middle of the Clinical Chemistry sequence, the system may get stuck in an "In Progress" status without showing an error message, which can lead to significant delays in providing patient test results. This issue specifically affects devices running software versions 1.3.3 and 1.3.4.
The software bug causes testing samples to stall in the system without alerting the operator to an error. This can lead to critical delays in medical diagnosis and patient treatment because healthcare providers may not receive necessary test results in a timely manner.
Firm initiated voluntary recall for software versions 1.3.3 and 1.3.4.
Firm initiated voluntary recall for software versions 1.3.3 and 1.3.4.
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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