China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) issued notice JGXX-2013-10020 regarding a voluntary global recall initiated by Ortho-Clinical Diagnostics, Inc. for its fully automated biochemical analyzers (Registration No.: CFDA (Imported) No. 20122401214). The recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., was prompted by a manufacturing issue where tension springs on certain VITROS systems may not meet specified manufacturing standards, potentially affecting product compliance and performance. While the recall is global, the official report explicitly states that it does not involve the Chinese market, with zero units of the affected products (e.g., Model 4600) having been sold or imported into China at the time of the report. Consequently, Ortho-Clinical Diagnostics, Inc. and its responsible unit in China are not required to take direct remedial actions within China beyond submitting the recall report to the State Food and Drug Administration (a predecessor to NMPA). The NMPA, however, instructed provincial food and drug administration departments to maintain vigilant supervision and management over such medical devices. The recall report was dated February 25, 2013, and publicly notified on March 20, 2013.