China NMPA Product Recall - Freedom EVO NAE Workstation, a fully automated enzyme immunoassay workstation and nucleic acid extraction and purification instrument.

DIKEN (Shanghai) Trading Co., Ltd. has initiated a voluntary Class III recall for several of its automated medical devices, specifically the fully automated enzyme immunoassay workstations and the fully automated nucleic acid extraction and purification instruments (Freedom EVO NAE Workstation). This recall was officially announced by the National Medical Products Administration (NMPA) on March 1, 2019. The fundamental issue prompting this action is a critical software malfunction identified in these instruments, linked to a specific date parameter within their operating software. This defect could potentially impact the reliable functioning of the devices. The regulatory framework for this action falls under the NMPA's medical device oversight, with the Shanghai Food and Drug Administration having issued relevant registration numbers, including 国械注进20172406573, 国食药监械（进）字2014第 2400032号, and 国械备20160221号. As a required action, DIKEN (Shanghai) Trading Co., Ltd. is actively recalling all affected product models, specifications, and batches to rectify this software problem, with detailed information provided in a "Medical Device Recall Event Report Form." This ensures product safety and adherence to regulatory standards.