China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its fully automated chemiluminescence immunoassay analyzer, as announced on June 25, 2019. This action, reported by the Shanghai Food and Drug Administration and the National Medical Products Administration, addresses a critical software issue identified in the Alinity ci-series. The problem arises when the system transitions abnormally from "processing" to "stopped" and subsequently to "standby." Under these specific conditions, there is a risk that reaction cups (RV cups) may be inadvertently reused. Such reuse has the potential to compromise the accuracy of subsequent test results, posing a significant concern for patient diagnostics and safety. The company proactively reported this defect and is undertaking the recall to mitigate the risk associated with these devices. Details regarding the specific product models, specifications, and affected batches are available in the accompanying Medical Device Recall Event Report Form. This recall underscores the importance of stringent software validation and immediate corrective actions in medical device manufacturing to ensure product reliability and patient well-being.