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

Instrumentation Laboratory Co., through its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a Class II voluntary recall of its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method) on August 15, 2017. This action was prompted by customer reports detailing performance issues with specific product batches, namely N0177760 and N1166235. Customers reported that some kits within these batches exceeded quality control limits, resulting in excessively long sample results, which could potentially compromise diagnostic accuracy for prothrombin time and fibrinogen concentration detection in patient plasma. The recall falls under the oversight of the National Medical Products Administration (NMPA) of China. The affected products, identified by Registration No.: 20152402017, are used globally for in vitro quantitative detection. As part of the corrective actions, Instrumentation Laboratory Co. and its agent were required to immediately cease sales of the affected batches within China. Furthermore, all existing inventory of these two problematic batches in China must be destroyed to prevent further distribution and use. This voluntary recall highlights the company's commitment to product safety and quality in response to identified performance deviations.