China NMPA Product Recall - NextSeq® 550Dx High Output Reagent Kits v2.5 (Universal Sequencing Reaction Kit for Sequencing Methods)

Inmina (China) Scientific Instruments Co., Ltd. initiated a voluntary Class III recall of its NextSeq® 550Dx High Output Reagent Kits v2.5, a universal sequencing reaction kit, as reported by the National Medical Products Administration (NMPA) on November 4, 2020. The recall stems from a manufacturing issue impacting a sub-component, specifically the NextSeq 550Dx High-Throughput Reagent Cartridge v2 (75 cycles/set). These cartridges may not have been properly sealed during production. The primary concern is that improper sealing can lead to underfilling during sequencing runs, potentially resulting in no or low cluster density, affecting the kit's performance. Furthermore, the kits contain hazardous materials, which, if leaked and with prolonged or repeated exposure, pose significant safety hazards including potential for cancer, impaired fertility, danger to unborn infants, and organ damage. Under the NMPA's regulatory guidance, Inmina (China) Scientific Instruments Co., Ltd. has taken action to remove the affected product from the market. Users are advised to consult the NextSeq 550Dx Instrument Reference Guide and wear appropriate personal protective equipment, such as goggles, gloves, and lab coats, to mitigate exposure risks in the event of a leak. Additional specifics on affected product models and batch numbers are detailed in the accompanying Medical Device Recall Event Report Form.