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 voluntary Level II recall of its Prothrombin Time and Fibrinogen Assay Kits (Coagulation Method). This action, reported to the National Medical Products Administration (NMPA) on October 26, 2017, and published on October 30, 2017, was prompted by customer reports of significant performance issues. Specifically, some kits, designed for in vitro quantitative detection of prothrombin time and fibrinogen concentration, exceeded quality control limits and produced excessively long results. Subsequent investigations identified two additional affected batches: N0278358 and N0479057. Under NMPA regulations, Wofen Medical Device Trading (Beijing) Co., Ltd. took several corrective actions. They immediately ceased sales of the affected batches within China, issued recall notices to customers requesting product returns, and offered replacement batches. Furthermore, all remaining inventory of the two affected batches in China, along with the products recalled from customers, were destroyed to prevent further use. While managed by the agent in China, this recall was declared as a global effort.