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

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Instrumentation Laboratory Co. on August 15, 2017. The recall, reported by its agent Wofen Medical Devices Trading (Beijing) Co., Ltd. on August 10, 2017, addresses performance issues with specific batches of their Prothrombin Time and Fibrinogen Assay Kits (Clotting Method). The affected product, identified by Registration No. 20152402017 and specifically impacting batch numbers N0177760 and N1166235, was found to have kits exceeding quality control limits and producing excessively long sample results. This issue could potentially affect the accuracy of in vitro quantitative detection of prothrombin time and fibrinogen concentration. Operating under the NMPA’s regulatory framework, Instrumentation Laboratory Co. and its agent are required to take immediate corrective actions. These include halting the sale of all affected product batches in China and destroying all remaining inventory of batch numbers N0177760 and N1166235 within China. While the recall applies globally, the specific sales quantity for affected products in China was reported as zero for batch N0177760. A Class II recall indicates that the product's use may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.