China NMPA Product Recall - Activation solution

Abbott Ireland Diagnostics initiated a voluntary Class III recall of its ARCHITECT TRIGGER SOLUTION. This action, reported by Abbott Trading (Shanghai) Co., Ltd., was prompted by the discovery that certain batches of the product, specifically those shipped to Vietnam, were missing required Vietnam-specific labels on their outer packaging. The recall notice, published on December 2, 2021, by the National Medical Products Administration (NMPA), highlights a compliance issue rather than a product quality or safety defect. The affected product, which holds Registration Certificate Code: 国械备20150075号, indicates its registration under the NMPA's regulatory framework. The company's required action is to retrieve the non-compliant products from the market. This voluntary recall demonstrates the company's commitment to adhering to international labeling regulations, even for regional markets, and ensures that all distributed products meet country-specific requirements.