China NMPA Product Recall - Pre-excitation liquid

The National Medical Products Administration (NMPA) announced on May 22, 2023, that Abbott Ireland Diagnostics Division has initiated a voluntary Level III recall of its pre-activation solution. This recall was reported by Abbott Trading (Shanghai) Co., Ltd. The primary issue leading to this action is the use of an incorrect registration mark on the affected medical device. The product in question, identified by National Medical Device Registration No. 20210177, is being recalled proactively by the manufacturer. A Level III recall signifies a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. This action aligns with the NMPA's regulatory oversight to ensure the accuracy and compliance of medical device labeling within China. Companies are mandated to adhere strictly to registration requirements to ensure product integrity and public safety. Further specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying 'Medical Device Recall Event Report Form' provided by Abbott. This voluntary recall underscores the manufacturer's commitment to addressing compliance discrepancies swiftly under the NMPA’s regulatory framework.