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

Instrumentation Laboratory Co. initiated a voluntary Level II recall of its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method), under the oversight of China's National Medical Products Administration (NMPA). This recall, reported on October 26, 2017, and officially published on October 30, 2017, was prompted by customer complaints concerning product performance. The core issue identified was that certain kits exceeded established quality control limits and produced unreliably long test results for prothrombin time and fibrinogen concentration. Further investigation confirmed two specific affected batches: N0278358 and N0479057. In response, Wofen Medical Device Trading (Beijing) Co., Ltd., acting as the company's agent, promptly ceased sales of the identified batches within China. They also issued formal recall notices to all affected customers, requesting the return of the compromised products and ensuring the provision of replacement kits. To prevent any further risk, all remaining inventory of the two affected batches in China, along with any products returned from customers, were systematically destroyed. This comprehensive action aimed to safeguard patient care by ensuring the accuracy of diagnostic testing.