China NMPA Product Recall - VITROS Chemical Products Water Vapor Adsorption Column Sales Unit Packaging Box

Ortho-Clinical Diagnostics, Inc. initiated a voluntary recall of sales unit packaging for its VITROS chemical product water vapor adsorption columns, as reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on December 26, 2012. The National Medical Products Administration (NMPA) published this information on January 14, 2013. The recall was prompted by the potential incorrect inclusion of other accessories within the packaging boxes for the VITROS adsorption columns. These columns are designed to mitigate water vapor contamination that could interfere with signal reagents in VITROS® System MicroWell experiments. Affected products are identified by CFDA Import/Export Medical Device Registration Nos. 20103400146, 20103400145, and 20113403289. While the recall is global, Ortho-Clinical Diagnostics, Inc. stated that it does not directly involve China, and consequently, no on-site corrective actions were taken within the country. However, under the NMPA's regulatory framework, provincial, autonomous region, and municipal food and drug administrations were requested to enhance their supervision and management over this category of products. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. serves as the company's responsible unit in China.