China NMPA Product Recall - Rheumatoid factor calibrator

Ortho Clinical Diagnostics, Inc., through its responsible unit Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary global recall of specific batches of its Rheumatoid Factor Calibrators. This action was reported on January 10, 2012, and publicly announced by the National Medical Products Administration (NMPA) on January 19, 2012. The primary reason for the recall was the failure of certain product batches, such as Batch Number 1630, to maintain their specified 12-month stability requirements. These calibrators are essential for the accurate quantitative determination of rheumatoid factor (RF) when used with VITROS 5,1FS and VITROS 5600 automated analyzers. Although the product, registered under CFDA (Imported) No. 20102402182, was manufactured in the USA and imported into China, the affected quantities were not sold within the Chinese market, as explicitly stated in the recall document. In response to this situation, the NMPA mandated that provincial, autonomous region, and municipal food and drug administrations strengthen their oversight and management of similar medical devices. The voluntary recall served as the immediate corrective action by the company.