China NMPA Product Recall - Blood analyzer (DxH600) and blood analyzer (DxH800)

The National Medical Products Administration (NMPA) has announced a Class I voluntary recall initiated by Beckman Coulter, Inc. The recall involves two models of blood analyzers, DxH600 (Registration Certificate No.: 20142405955) and DxH800 (Registration Certificate No.: 20172401617). The reason for this critical recall is the potential for these devices to occasionally produce erroneous increases in platelet count readings. Beckman Coulter Trading (China) Co., Ltd. reported this issue, leading to the manufacturer's decision. A Class I recall signifies the most serious type of recall, indicating that there is a reasonable probability that using these products will cause serious adverse health consequences or death. The NMPA's involvement ensures public awareness and regulatory oversight of this significant medical device safety matter. Further details regarding specific product batches and specifications are available in the 'Medical Device Recall Event Report Form' attached to the original notification, emphasizing the importance of careful review for affected healthcare providers.