China NMPA Product Recall - Factor XII Detection Kit (Coagulation Method)

Instrumentation Laboratory Co. initiated a voluntary Class III recall of its Factor XII Detection Kit (Coagulation Method), registered under National Medical Device Registration Certificate 20162404775. This recall, reported to the National Medical Products Administration (NMPA) on July 31, 2017, and released on August 2, 2017, was prompted by an internal investigation by IL. The primary issue identified was that affected batches of the kit (product code 0020011200) failed to meet their declared onboard stability of 24 hours at 150C when used on ACL Top family instruments. Subsequent testing revealed the actual stability is only 2 hours. This discrepancy impacts the product's performance specifications. Operating under NMPA regulations, Instrumentation Laboratory, through its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., is taking several corrective actions. These include immediately discontinuing sales of the affected product batches globally. Furthermore, customers must be formally notified via letter about the reduced onboard stability time, and records of these notifications and customer acknowledgements must be maintained. Laboratories are also reminded to perform annual quality control checks in line with established management regulations. The recall affects specific batches, with 104 units sold in China.