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

Ortho-Clinical Diagnostics, Inc., in cooperation with its Chinese representative Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary global recall of its Phenobarbital Assay Tablets (Immunometry). This action, reported on June 28, 2011, and publicized by the National Medical Products Administration (NMPA) on September 9, 2011, addresses critical quality control issues. The recall specifically targets products with coating number 0053, which were found to exhibit occasional inaccuracies, abnormalities, and deviations in quality control values. These tablets are designed for the quantitative determination of phenobarbital concentration in serum and plasma, indicating a potential impact on patient diagnostics and safety. The regulatory context for this imported medical device in China is governed by the NMPA, under registration certificate CFDA (Imported) No. 20093402271. In response to customer feedback and internal investigation, Ortho-Clinical Diagnostics confirmed the defect. Consequently, the company has mandated two primary corrective actions: immediately stopping the sale and destroying all remaining Phenobarbital Assay Tablets with coating number 0053, and recalling and destroying all previously sold units of this identified batch. This proactive measure aims to mitigate any risks associated with the faulty product.