China NMPA Product Recall - Phenytoin assay dry slides (immunorate rate method)

The National Medical Products Administration (NMPA) issued a report on September 4, 2014, concerning a voluntary recall by Ortho-Clinical Diagnostics, Inc. for its Phenytoin Assay Dry Tablets (Immunometry), specifically batch number 2613-0150-4913. The recall, first reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on August 28, 2014, addresses the potential for biased results, including positive biases. This issue could lead to inaccurate quantitative determination of phenytoin concentrations in patient serum and plasma when the product is used with various VITROS automated biochemical analyzers.

Operating under the NMPA's regulatory framework, referencing CFDA Import Permit No. 20122404635, the manufacturer initiated a global recall. However, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. verified that the affected batch was not sold or imported into the Chinese market. Therefore, beyond the initial notification to the NMPA, no additional recall actions, such as investigation plans or summary reports, will be undertaken by the distributor for products within China. Provincial food and drug administrations were instructed to enhance their supervision and management of similar medical devices to safeguard public health.