China NMPA Product Recall - Alinity's System Fully Automated Chemiluminescence Immunoassay Analyzer

Abbott Trading (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its Alinitys System fully automated chemiluminescence immunoassay analyzer, specifically for units operating with software version 2.7.1 and earlier. This recall, announced by the National Medical Products Administration (NMPA) on October 19, 2021, addresses a significant safety concern regarding potential operational hazards.The main issue arises from a software anomaly: if the maintenance and diagnostic procedure 8900 is initiated from a stopped state when the R1 pipette probe is bent and a sample rack is present on the aspiration platform, there is a risk. This specific condition could lead to biohazardous exposure from sample spillage and/or operator injury due to sample tube breakage. To mitigate these risks, Abbott Trading (Shanghai) Co., Ltd. is undertaking this voluntary recall action. Further details on the affected product models, specifications, and batches are provided in the "Medical Device Recall Event Report Form." This action highlights the company's adherence to regulatory standards and commitment to ensuring product safety for both operators and patients.