China NMPA Product Recall - Lipase Assay Kit (Enzymatic Method)

Beckman Coulter, Inc., in cooperation with its agent Beckman Coulter Trading (China) Co., Ltd., initiated a voluntary Class III recall of its Lipase Assay Kit (Enzymatic Method). The recall, reported to the National Medical Products Administration (NMPA) on September 25, 2018, was prompted by concerns regarding batch M712448. Testing revealed that this specific batch exhibited a lower recovery rate compared to previous lots when used for quality control and patient sample analysis. This issue could cause quality control results to fall below the laboratory's established lower limit. However, the manufacturer determined that the clinical impact on patient diagnosis is minimal, therefore retrospective review of patient results is not required. While the affected products (batch M712448) were not sold in China, the recall impacts regions including the USA, Canada, and Italy. The action reflects adherence to regulatory frameworks to address product performance deviations and ensure medical device reliability.