China NMPA Product Recall - Diluent for Biochemical Analyzers

On April 8, 2014, the National Medical Products Administration (NMPA) received a report from Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. concerning a voluntary global recall initiated by its manufacturer, Ortho-Clinical Diagnostics, Inc. The recall involves two types of diluents for biochemical analyzers (Registration Certificate Nos.: CFDA (Imported) 2012 No. 1404440 and CFDA 2013 No. 1402367). The primary issue identified is that C-reactive protein (CRP) results obtained from diluted samples using specific batches of these diluents (Product Codes 8559825 and 6801754, Batch Numbers F3168 and 01-3266) may be lower than anticipated, potentially leading to inaccurate diagnostic information. These diluents are intended for use with various VITROS fully automated biochemical and immunoassay analyzers. Under the NMPA's regulatory framework, a significant finding for the Chinese market is that the affected product batches were not imported into the country. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. will not undertake direct recall actions within China beyond the initial notification. However, all provincial food and drug administrations are instructed to strengthen their supervision and management of similar biochemical analyzer diluents to uphold product safety and quality across the region.