China NMPA Product Recall - Blood gas analyzer

On June 19, 2017, the National Medical Products Administration (NMPA) announced a voluntary recall initiated by Radomet Medical Equipment (Shanghai) Co., Ltd. This action concerns their blood gas analyzers, specifically those identified under Registration No.: 20132404943. The primary issue prompting this recall is a significant malfunction encountered when users attempt to input specific blood sample types, namely "umbilical artery blood" or "umbilical vein blood," into the device. This operational flaw could lead to inaccuracies or difficulties in processing critical patient data. The recall has been designated as a Class III event, indicating a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. Radomet Medical Equipment (Shanghai) Co., Ltd. is responsible for implementing this recall as per the regulatory framework overseen by the NMPA for medical devices. Further details regarding the specific models, specifications, and batch numbers of the affected products are documented in the accompanying "Medical Device Recall Event Report Form." This voluntary action underscores the company's commitment to product safety and compliance with national medical device regulations, ensuring the reliability of diagnostic equipment.