China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

On January 2, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its fully automated chemiluminescence immunoassay analyzer. This action was prompted by potential issues identified with the device, specifically foaming or bubbling, and unexpected crystallization of buffer on the exterior of the concentrated cleaning buffer reservoir. The affected product, registered under certificate No. 20183400031, necessitates this recall to address the quality concerns. Overseen by the National Medical Products Administration (NMPA), this voluntary recall highlights the company's responsibility to manage product safety under the regulatory framework. While no specific inspection dates were provided in the recall announcement, the company's proactive measure aligns with regulatory expectations. Abbott Trading (Shanghai) Co., Ltd. is required to furnish comprehensive details regarding the specific models, specifications, and batch numbers of the affected products, which are available in the associated "Medical Device Recall Event Report Form" for stakeholders and affected parties. The company is taking the necessary steps to address the identified product deficiencies and manage the recall effectively in accordance with NMPA guidelines.