China NMPA Product Recall - Alinity c Fully Automated Biochemical Analyzer

On June 19, 2020, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary recall of its Alinity c fully automated biochemical analyzer under the oversight of the National Medical Products Administration (NMPA). The recall, classified as Level III, was prompted by identified performance issues within the device's optical system. Specifically, concerns include a potential for nonlinear optical system response and the diffraction grating component possibly causing absorbance values to be lower than expected. These issues could affect the accuracy and reliability of diagnostic test results. Abbott Trading (Shanghai) Co., Ltd. proactively reported these findings. Detailed information regarding the specific models, specifications, and batches of affected products is available in a supplementary Medical Device Recall Event Report Form. This action underscores the company's commitment to product quality and patient safety, addressing potential inaccuracies in their medical diagnostic equipment to maintain clinical reliability.