China NMPA Product Recall - Fully automated blood cell analyzer

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall for its fully automated hematology analyzer (Registration Certificate No.: 20182220358). This action, publicized by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on March 6, 2019, stems from internal company investigations. The core issue identified is a significant flaw in the analyzer's operational safety: should the bleaching cycle be interrupted or prematurely terminated, the system fails to provide any warning to the operator. This critical deficiency means the device cannot adequately eliminate residual bleach before proceeding with sample analysis. The presence of unremoved residual bleach could potentially compromise the accuracy and reliability of diagnostic results, thereby impacting patient care. Beckman Coulter is undertaking this recall to address the product deficiency and ensure device integrity. Specific product models, specifications, and affected batches are detailed in the accompanying "Medical Device Recall Event Report Form." This situation underscores the rigorous oversight of medical device safety by regulatory bodies like the NMPA, compelling manufacturers to promptly address any identified product defects to safeguard public health.