Abbott Laboratories is recalling 11,653 units of the Alinity ci-series System Control Module (SCM) due to a software defect in versions 3.6.1 and lower. This chemistry and immunoassay analyzer, manufactured in the United States, is being corrected because it may produce incorrect test results for multiple analytes. Laboratory professionals should follow the specific software update instructions provided by Abbott to fix the issue.
Software versions 3.6.1 and lower can cause the system to generate erroneous clinical results for various analytes, which could lead to incorrect medical diagnoses or inappropriate treatment decisions. The issue was discovered by the manufacturer during internal testing following complaint investigations.
Software correction to prevent erroneous results.
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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