China NMPA Product Recall - Mycobacterium tuberculosis and rifampicin resistance gene detection kit (real-time fluorescence PCR-melting curve method) Xpert® MTB/RIF Ultra

Cepheid (Shanghai) Trading Co., Ltd. has reported a voluntary Class III recall initiated by its manufacturer, Cepheid AB of Sweden, regarding the Mycobacterium tuberculosis and Rifampicin Resistance Gene Detection Kit (Real-time Fluorescence PCR-Melting Curve Method), specifically the Xpert R MTB/RIF Ultra. This diagnostic kit, registered under National Medical Device Registration No. 20233400073, is being recalled because its stability data did not meet acceptable quality standards. The National Medical Products Administration (NMPA) of China oversees this regulatory action, which was publicly announced on June 19, 2024. While a Class III recall indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences, it still necessitates corrective action due to quality deficiencies. Importantly, Cepheid (Shanghai) Trading Co., Ltd. confirmed that the specific products subject to this recall were not imported into the Chinese market. A detailed "Medical Device Recall Event Report Form," submitted by the company, provides comprehensive information on the involved models and lot numbers, ensuring compliance with NMPA's regulatory framework for medical device safety and quality.