Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer (Model C11137) because it may experience system errors during the aspiration process that cause calibration curves to switch from 'passed' to 'failed.' This anomaly affects 67 units in the United States and 178 units internationally. If unnoticed, these errors can cause processing delays or erroneous measurement results in clinical laboratory testing.
The calibration issues can cause the system to misinterpret data, leading to incorrect diagnostic test results being sent to Laboratory Information Systems. While no injuries have been reported, inaccurate test results could lead to incorrect medical diagnoses or inappropriate patient treatment decisions.
Recall #: Z-1996-2025
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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