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

Instrumentation Laboratory Co., through its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a Class III voluntary recall of its Factor XII Detection Kit (Coagulation Method) (product code 0020011200). This recall, announced on August 2, 2017, under the oversight of the National Medical Products Administration (NMPA) (Registration Certificate 20162404775), stems from an internal identification that affected batches of the kit did not meet their declared onboard stability. Originally stated as 24 hours at 15

C on ACL Top family instruments, current data demonstrated a significantly reduced stability of only 2 hours.

As required actions, sales of all affected batches were immediately halted. Instrumentation Laboratory Co. is instructing its agent to promptly inform customers via official letters about the revised 2-hour onboard stability. Customers are also required to retain proof of notification and feedback. Furthermore, laboratories are advised to conduct annual quality control procedures in line with standard management regulations. This global recall affects 104 units in China across specific batch numbers (N1065905, N0764104, N0958653). The primary issue is the discrepancy between declared and actual product stability, impacting reliable diagnostic performance.