China NMPA Product Recall - Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Chemiluminescence Immunoassay Analyzer, Fully Automated Biochemical Analyzer Alinity c

On March 22, 2019, Abbott Trading (Shanghai) Co., Ltd., under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, initiated a voluntary Class II recall for specific fully automated chemiluminescence immunoassay analyzers and the fully automated biochemical analyzer Alinity c. The core issue prompting this action is a potential malfunction of the safety interlock device. This device is designed to secure and cover a soft-cap puncture needle within the solution bottle rack once a bottle is removed, thereby preventing user exposure and ensuring operational safety. The company identified that this safety interlock mechanism might not deploy as intended, potentially leaving the puncture needle uncovered. While Abbott Trading (Shanghai) Co., Ltd. assessed the risk of needlestick injuries as extremely rare due to the needle's difficult-to-reach location, the recall was initiated to proactively address this potential safety concern. Further specifics regarding the affected product models, specifications, and batch numbers are detailed in an accompanying Medical Device Recall Event Report Form. This voluntary recall highlights the company's commitment to maintaining product safety and adhering to regulatory standards.