China NMPA Product Recall - Microbial culture instrument

Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Level III recall of its microbial culture instruments on September 14, 2020, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. This action followed a notification from the manufacturer, Remel, Inc., concerning an essential software upgrade for the SBC Software 2.0.2.2. The purpose of this upgrade is to resolve potential issues identified with the current software version installed in the instruments. The primary concerns with the existing software primarily manifest as workflow interruptions during the operation of the microbial culture instruments. Crucially, the company has clarified that these software-related issues are not anticipated to impact patient test results, mitigating direct patient safety risks. The recall specifically targets manufactured microbial culture instruments under Registration Certificate No.: 国械注进20182401763, with detailed product models, specifications, and batches provided in the accompanying "Medical Device Recall Event Report Form." Thermo Fisher Scientific (China) Co., Ltd. is actively addressing these issues to ensure the continued reliability and operational efficiency of their medical devices, adhering to the regulatory standards set by the NMPA.