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 Level II voluntary recall for its Prothrombin Time and Fibrinogen Assay Kits (Coagulation Method) (Registration Number: "国械注进20152402017"). The recall was prompted by customer reports detailing performance issues, specifically some kits exceeding quality control limits and yielding excessively long results. Two additional affected batches, N0278358 and N0479057, were identified, impacting 1156 units globally, with 150 units sold in China. Under the National Medical Products Administration (NMPA) framework, Wofen Medical Device Trading (Beijing) Co., Ltd. ceased sales of the problematic batches in China, issued recall notices to customers requesting the return of affected products for replacement, and ensured the destruction of all remaining inventory and recalled kits. These actions were taken to prevent inaccurate diagnostic results for patients.