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

Instrumentation Laboratory Co., via its agent Wofen Medical Device Trading (Beijing) Co., Ltd., conducted a voluntary Level II recall of its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method) in October 2017. This action was initiated due to customer reports detailing performance issues, specifically that certain kits exceeded quality control limits and yielded excessively long results. Two batches, N0278358 and N0479057, were identified as affected. This recall was managed under the regulatory framework of the National Medical Products Administration (NMPA) of China, for a product with registration number 国械注进20152402017. The recall had a global scope, with 150 affected units sold in China. Required actions included Wofen Medical Devices Trading (Beijing) Co., Ltd. ceasing sales of the identified batches in China, dispatching recall notices to customers requesting the return of affected products, providing replacement batches, and destroying all remaining inventory and successfully recalled products to ensure public safety.