China NMPA Product Recall - VITROS 5600 Integrated System, VITRC Integrated System, VITROS 3600 Immunodiagnostic System, VITROS 4 Chemistry System, and VITROS XT 3400 Chemistry System are all fully automated biochemical and immunoassay analyzers.

On November 1, 2023, Ortho-Clinical Medical Devices Trading (China) Co., Ltd. announced a voluntary Class II recall on behalf of its manufacturer, Ortho-Clinical Diagnostics, Inc. This action, reported to the National Medical Products Administration (NMPA), addresses a documented increase in software problems affecting the operation of VITROS® analyzer systems running software version V3.8.0. The core issue involves operational software malfunctions impacting the reliability of several automated biochemical and immunoassay analyzers. This prompted Ortho-Clinical Diagnostics, Inc. to initiate a proactive recall to uphold product integrity and patient safety standards. The recall specifically targets numerous NMPA-registered medical devices, including the VITROS 5600 Integrated Automated Biochemical and Immunoassay Analyzer, VITRC Integrated System, VITROS 3600 Immunodiagnostic System, VITROS 4 Chemistry System, and the VITROS XT 3400 Chemistry System. Under the NMPA's regulatory guidelines, a Class II recall is designated for situations where product use or exposure could lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. The company's required action is this voluntary recall, aimed at addressing the identified software deficiencies and ensuring continued compliance with medical device regulations.