China NMPA Product Recall - Fully automated blood cell analyzer

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its fully automated hematology analyzer (Registration Certificate No.: 国械注进20182), as announced by the National Medical Products Administration (NMPA) on March 8, 2019. This action follows an internal company investigation that identified a critical operational flaw. The investigation revealed that if the analyzer's bleaching cycle is interrupted or prematurely terminated, the system fails to alert the operator. Crucially, the device also proved incapable of sufficiently removing residual bleach prior to analyzing subsequent samples. This could potentially compromise the accuracy and reliability of diagnostic results due to contamination. The company is taking proactive steps to address this issue by recalling affected units. Further specifics regarding the models, specifications, and batches impacted by this recall are provided in the comprehensive "Medical Device Recall Event Report Form." This recall underscores the importance of stringent quality control and system integrity in medical diagnostic equipment to ensure patient safety and data accuracy.