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 voluntary Level II recall for specific batches of its Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method). This action, reported on August 10, 2017, and published by the National Medical Products Administration (NMPA) on August 21, 2017, followed recent customer complaints regarding the product's performance. The primary issue, identified in batch numbers N1166235 and N0177760, indicated that some kits exceeded quality control limits, resulting in excessively long sample results. These performance deficiencies could compromise the accurate quantitative detection of prothrombin time and fibrinogen concentration in plasma. Operating under the NMPA's regulatory framework, a Level II recall signifies a situation where the use of a non-conforming product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a corrective action, Instrumentation Laboratory Co. mandated a global recall, with specific instructions for China to immediately cease sales and destroy all existing inventory of the two affected batches within the country. This measure aims to prevent further distribution and use of the non-conforming diagnostic kits.