China NMPA Product Recall - Alinitys System Fully Automated Chemiluminescence Immunoassay Analyzer

On December 16, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Alinitys System Fully Automated Chemiluminescence Immunoassay Analyzers. The recall stems from an internal discovery by Abbott concerning a significant labeling non-conformance. Specifically, instruments distributed for use in China were found to be missing the required Chinese language label upon installation at customer locations, indicating a deviation from local regulatory stipulations. This corrective action is implemented under the regulatory oversight of the National Medical Products Administration (NMPA) of China, as reported by the Shanghai Municipal Drug Administration. The affected medical devices, identifiable by Registration Certificate No. "国械注进20193400001", are being recalled to rectify this compliance issue. Abbott Trading (Shanghai) Co., Ltd. is undertaking this voluntary recall to ensure adherence to Chinese medical device regulations, emphasizing the importance of accurate and complete product labeling. While specific inspection dates are not mentioned as this was a company-initiated discovery, the required action is the comprehensive recall of the non-compliant units, with further details on affected batches available in the Medical Device Recall Event Report Form.