China NMPA Product Recall - Quality control products for blood analyzers

The National Medical Products Administration (NMPA) published an index on October 8, 2011, detailing a voluntary recall initiated by Beckman Coulter. Beckman Coulter Trading (China) Co., Ltd. reported the recall on September 15, 2011, for specific quality control products utilized with COULTER Ac T 5diff series blood analyzers. The recall, impacting regions such as the United States and Canada but explicitly not involving the Chinese market, pertains to batch number 370511 (Item Number 7547198) of their Quality Control Materials for Blood Analyzers. The primary issue identified was that the eosinophil percentage (E0%) and absolute eosinophil count (EO#) values might exceed the acceptable quality control recovery rate range when used at normal control levels. Beckman Coulter recommended that users establish their own laboratory average and range for the quality material's recovery rate and monitor for increased eosinophil recovery. These actions align with existing product label guidance for customers to define laboratory-specific averages and acceptable ranges. The NMPA instructed its provincial and municipal administrations to enhance supervision over such products.