Ortho-Clinical Diagnostics is recalling approximately 557 VITROS laboratory systems, including models 3600, 4600, 5600, XT 3400, and XT 7600, running Software Version 3.8.0. These medical diagnostic systems are experiencing software issues that cause the screen to freeze, subsystems to become unresponsive, or printers to disconnect. These technical failures require a full system shutdown and restart to recover, which leads to significant delays in reporting critical patient test results. Because this software must be manually installed by a technician, a field engineer is required to resolve the issue on each affected unit.
The software defects cause system freezes that delay the reporting of medical test results, including emergency (STAT) assays where speed is critical. Such delays can lead to a dangerous postponement of patient treatment or life-saving medical interventions.
Field Engineer manual installation/repair
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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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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