China NMPA Product Recall - Multi-channel sample feeding machine

On September 16, 2019, the National Medical Products Administration (NMPA) announced that Diken (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its multi-channel plugging machine. The recall stems from a significant safety concern identified with the device's adjustable front cover and dust cover. The primary issue involves the aging of the gas spring mechanism, which is designed to support these covers. Over time, the gas spring can lose its resistance, leading to the front panel detaching from its upright position, falling, or remaining partially open. This malfunction presents a clear risk of minor to moderate injury for operators who could be struck by the falling panel. Operating under the oversight of the NMPA, which previously granted the device regulatory approval (CFDA (Imported) 2005 No. 2401579), Diken (Shanghai) Trading Co., Ltd. proactively took this corrective action. The company is required to manage the recall process, with specific details concerning affected models, specifications, and batch numbers outlined in a supplementary Medical Device Recall Event Report Form. This recall highlights the manufacturer's responsibility to address design-related safety deficiencies in medical devices to protect users.