China NMPA Product Recall - Fully Automated Biochemical and Immunological Analyzer

Ortho-Clinical Diagnostics, Inc., through Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., issued a voluntary recall notification on May 2, 2012, with publication by the National Medical Products Administration (NMPA) on May 23, 2012. The recall addresses a potential software malfunction in specific models of its fully automated biochemical and immunoassay analyzers, specifically the VITROS® 5600, running software version 1.6 or lower. The primary issue arises when conducting drug abuse testing (DAT), where a software anomaly could cause incorrect surfactant additives to be dispensed, potentially affecting other test results. The regulatory framework for this announcement is the National Medical Products Administration in China. However, the company explicitly stated that this recall does not involve the Chinese market. The reason for this exclusion is that the DAT products related to the recall are not registered in China, and the affected VITROS® 5600 systems are not used for DAT testing within China. Consequently, the described software anomaly will not occur for products in the Chinese market. Therefore, no direct recall actions were required or implemented for products within China. Instead, all provincial, autonomous region, and municipal food and drug administrations were requested to strengthen their supervision and management of such medical devices.