China NMPA Product Recall - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis System and Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis Instrument System

The National Medical Products Administration (NMPA) published a recall notice on April 19, 2013, concerning bioMerieux.Inc.'s fully automated microbial identification and antimicrobial susceptibility analysis systems. Specifically, the recall, initiated voluntarily by bioMerieux, affects certain models of the VITEK 2 System (CFDA (Imported) 2011 No. 2403275) and VITEK 2 Compact System (CFDA (Imported) 2009 No. 2402809), with 1887 and 1770 units imported and sold in China, respectively. The primary issue identified, reported on April 3, 2013, is a critical software malfunction under specific conditions. This flaw can lead to a mismatch between test results generated by the systems and patient records when connected to a laboratory information management system (LIS), potentially compromising patient safety and treatment accuracy. In response to this significant concern, bioMerieux Diagnostics Products (Shanghai) Co., Ltd., the responsible entity in China, is undertaking several corrective actions. These include dispatching customer letters and incident confirmation forms to all affected agents and end customers, ensuring receipt confirmation. Furthermore, bioMérieux headquarters plans to release a new software upgrade, version 7.01, in November 2013, designed to mitigate the likelihood of this data mismatch. The NMPA has also directed regional food and drug administrations to intensify supervision of these products.