Beckman Coulter, Inc. is recalling 164 units of the DxI 9000 Access Immunoassay Analyzer, model REF #C11137, because a software defect allows the machine to use expired materials for calibration. When the system is set to automatically request calibration, it may use expired calibrator lots, which can lead to the machine reporting incorrectly high or low patient test results to doctors. This device is used in medical settings to measure various chemical levels in human body fluids.
The use of expired calibration materials can create an inaccurate baseline for medical tests, causing the analyzer to produce erroneous diagnostic data. This poses a risk of medical mismanagement where patients might receive unnecessary treatment or have critical conditions overlooked due to false laboratory results.
Corrective action for software defect
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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