China NMPA Product Recall - VITROS 5600 Fully Automated Biochemical and Immunoassay Analyzer

Ortho-Clinical Diagnostics, Inc., in collaboration with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall for its VITROS 5600 Automated Biochemical and Immunoassay Analyzer. This action, reported to China's National Medical Products Administration (NMPA) on December 7, 2010, addressed a critical system version setting issue. The core problem manifested as an immediate shutdown of analyzers equipped with version 1.5 software, specifically when users attempted to search for samples via the "Analyzer Status - View Sample Tray Status" option. This malfunction resulted in the cancellation of samples under processing. Despite impacting device functionality, the harm assessment concluded "no safety hazard present" to patients. Under NMPA's regulatory oversight, the recall targeted all VITROS 5600 units operating with the problematic 1.5 software version globally. While 25 units of the VITROS 5600 model were imported into China under registration certificate CFDA (Imported) No. 20103400145, it was determined that no analyzers with the specific version 1.5 software were present or affected in the Chinese market at the time of the recall. Consequently, no direct corrective actions were necessary within China for this particular software-related incident, although NMPA requested provincial administrations to acknowledge the recall.