Ortho-Clinical Diagnostics is recalling approximately 282 VITROS laboratory diagnostic systems, including the VITROS 3600, 4600, 5600, XT 3400, and XT 7600 models, due to a software defect in versions 3.8.0 and 3.8.1. The defect prevents the systems from properly reporting Westgard quality control flags when a new control is defined, which can lead the system to accept invalid test results. This failure to alert laboratory staff may cause incorrect patient diagnostic results to be reported, which could lead to inappropriate medical decisions. These systems were distributed worldwide and manufactured in the United States.
The software defect causes the system to miss statistical failures in quality control testing, allowing the machine to process patient samples even when it is not performing accurately. This poses a risk of erroneous patient results, which may lead to incorrect diagnoses or delayed treatments.
Software correction and diagnostic review
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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