China NMPA Product Recall - VITEK 2 System Fully Automated Microbial Identification and Antimicrobial Susceptibility Analyzer

On May 6, 2022, the National Medical Products Administration (NMPA) issued a notice concerning a voluntary Class III recall initiated by BioMerieux Inc. and reported by BioMerieux Diagnostics Products (Shanghai) Co., Ltd. The recall specifically addresses the VITEK 2 System Automated Microbial Identification and Antimicrobial Susceptibility Analyzer, identified by Registration Certificate No.: 20152220990. The primary issue identified, which led to this action, is the display of erroneous test results by the VITEK 2 System on Laboratory Information Systems (LIS) for specific models and batches of the analyzer. This malfunction raises concerns regarding the accuracy of diagnostic information, which is critical for appropriate medical decision-making. As a required action under the NMPA's regulatory framework, BioMerieux Inc. is conducting a voluntary recall of the affected VITEK 2 System units. Comprehensive details regarding the precise models, specifications, and batch information of the impacted products are provided in the "Medical Device Recall Event Report Form," which accompanies the official NMPA announcement. The company is expected to address the root cause of these erroneous results and implement corrective measures to prevent future occurrences.