China NMPA Product Recall - Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method)

Instrumentation Laboratory Co., through its agent Wofen Medical Device Trading (Beijing) Co., Ltd., initiated a voluntary Level II recall of its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method) in October 2017. This action, reported to the National Medical Products Administration (NMPA) of China, stemmed from customer reports indicating significant performance issues with the kits. Specifically, some batches were found to exceed quality control limits and produce excessively long patient results, leading to potential inaccuracies in diagnostic testing. An investigation identified two key affected batches, N0278358 and N0479057, impacting products registered under code 国械注进20152402017. These kits are intended for in vitro quantitative detection of prothrombin time and fibrinogen concentration in plasma. While the recall had a global scope, 150 units of the affected 20mL model were sold in China. In response to these findings, Wofen Medical Device Trading (Beijing) Co., Ltd. immediately ceased sales of the problematic batches within China. They promptly issued recall notices to affected customers, providing clear instructions for returning the implicated products and arranging for replacements. Furthermore, all remaining inventory of the affected batches in China, along with the products returned from customers, were securely destroyed to prevent any further use and mitigate potential patient risks associated with the performance discrepancies.