China NMPA Product Recall - Glucose, lactic acid, and urea electrode boxes

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its glucose, lactic acid, and urea electrode kits (Registration No. 20142403745). The recall, publicly reported on July 14, 2017, was prompted by the discovery of a software issue within the product. This identified defect has the potential to compromise the accuracy of urea value detection results, which are critical for diagnostic purposes. While specific inspection dates are not detailed in the announcement, the company's prompt action reflects its commitment to product safety. The recall, overseen by the National Medical Products Administration (NMPA), requires the company to remove the affected kits from distribution to safeguard patient safety and ensure the reliability of diagnostic testing. Detailed information regarding the specific models, specifications, and batch numbers of the impacted products is available in the associated "Medical Device Recall Event Report Form" attachments. This proactive measure underscores the company's responsibility in maintaining high product quality under the regulatory framework of the NMPA.