China NMPA Product Recall - Microalbumin Assay Kit

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Microalbumin Assay Kit. The recall, reported to the National Medical Products Administration (NMPA) on June 19, 2017, stems from the company's own quality control testing, which revealed that the product exceeded its permissible operational range. The affected product, identified by Registration No.: 20142405048, was found to have quality inconsistencies during internal assessments. While specific inspection dates are not detailed in the document, the company proactively identified and reported the deviation, leading to the product's withdrawal from the market. The Class III designation indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. This action by Beckman Coulter Trading (China) Co., Ltd. demonstrates adherence to the regulatory requirements set forth by the NMPA, which oversees medical device safety and quality in China. The company's immediate response to its internal quality control findings underscores its commitment to product integrity and patient safety. Further specifics regarding the model, specifications, and batch numbers of the affected kits are detailed in an attached Medical Device Recall Event Report Form, ensuring transparency in the recall process.