Beckman Coulter is recalling 143 DxC 500 AU Clinical Chemistry Analyzers because a software defect in versions V1.3 through V1.4.3 can lead to incorrect laboratory test results. When a lab technician reruns certain tests, the system may fail to update the final calculated result with the new data, reporting the initial (and potentially incorrect) result instead. This issue was discovered through internal company testing and affects 74 units in the United States and 69 units internationally.
The software defect may cause the system to report incorrect results or cause a delay in reporting patient results, which can impact medical treatment decisions. No injuries or patient incidents have been reported to date.
Automated chemistry analyzer for in vitro diagnostic use.
Automated chemistry analyzer for in vitro diagnostic use.
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.
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Sources: FDA iRES · Raw API Response
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