China NMPA Product Recall - NucliSENS easyMAG Extraction Reagents

bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Level III recall of specific batches of its NucliSENS easyMAG Nucleic Acid Extraction Reagents, as reported by the National Medical Products Administration (NMPA) on September 30, 2016. This action followed complaints received by bioMérieux's headquarters regarding amplification performance issues. The core problem identified was that nucleic acids extracted using the company's instruments and affected reagent batches sometimes experienced delayed Ct values during user-defined downstream PCR and RT-PCR experiments. This could potentially lead to false negative or invalid results, particularly when double-stranded nucleic acid extraction volumes exceeded 400 microliters. The affected product, Item Number 280133, is designed for use with the NucliSENS easyMAG nucleic acid extractor. An investigation clarified that these affected products are primarily utilized for data analysis and research purposes by institutions like disease control centers, and are not intended for clinical diagnostic use. Furthermore, the performance of the reagents remains unaffected when used with bioMérieux's proprietary downstream nucleic acid detection kits. In response to the issue, bioMérieux promptly notified affected customers via letter, outlining the situation and necessary steps to be taken. This recall impacts 67 boxes of the specified reagent batches sold in China.