China NMPA Product Recall - Navios flow cytometer

Beckman Coulter Trading (China) Co., Ltd., acting on behalf of manufacturer Beckman Coulter Ireland, Inc., initiated a voluntary Class III recall of its Navios Flow Cytometer on August 6, 2015. The recall was prompted by a detected defect in the embedded software, specifically version 1.1, which could produce inaccurate results if data graphs and outcomes were not meticulously verified against the instruction manual's guidelines. This issue impacts all versions of the Navios Flow Cytometer, with 14 units sold or imported into China. The recall was reported under the regulatory framework of the National Medical Products Administration (NMPA) of China, signifying compliance with Chinese medical device regulations for imported products. As a required corrective action, Beckman Coulter committed to upgrading the software on all affected devices to version 1.3 by June 1, 2016. Simultaneously, the company is updating the product's registration certificate to reflect these software enhancements, aiming to ensure product safety and reliability for its clinical medicine applications.