China NMPA Product Recall - Multiple biochemical calibrators

Beckman Coulter Trading (China) Co., Ltd. initiated a Class III voluntary recall for specific batches of its Multiple Biochemical Calibrators (Registration No. Guoshan 20152401835), as reported on July 27, 2017, to the National Medical Products Administration (NMPA). The recall stemmed from a confirmed negative bias in the sodium ion recovery value when testing Synchron Level 3 quality control products after calibration with AQUA calibration solution 1 (batch number 72645074). Linearity studies indicated a potential maximum negative bias of 8 mmol/L within the 150-180 mmol/L range for sodium ions, impacting product item number 471288, batch 72645074. These calibrators are globally distributed and used for the calibration of various analytes including sodium, potassium, and glucose. To address this issue, Beckman Coulter has implemented several corrective actions. The company issued user letters to affected customers to inform them of the defect. All identified affected products are being recalled, and customers will receive appropriate compensation. Following the recall, the products will undergo unified destruction within China. Upon completion of customer compensation in China, Beckman Coulter is required to submit a comprehensive summary report to the State Food and Drug Administration, ensuring regulatory compliance under the NMPA framework. This action emphasizes the company's commitment to product safety and quality assurance.