China NMPA Product Recall - Factor XI assay kit (coagulation method)

Instrumentation Laboratory Co., through its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a voluntary Class III recall for its Factor XII Detection Kit (Coagulation Method) (Registration No.: 20162404775). This recall was reported to the National Medical Products Administration (NMPA) on July 31, 2017, with a public release on August 2, 2017. The primary issue identified was that specific batches of the Factor XII Detection Kit (product code 0020011200) failed to meet their declared onboard stability of 24 hours at 15°C when used on ACL Top family instruments. Internal assessment confirmed the actual onboard stability for these kits is only 2 hours, potentially impacting the reliable quantitative detection of coagulation factor II activity. As required corrective actions, sales of the affected batches have been discontinued. Customers who received the kits must be promptly notified via an official letter detailing the reduced 2-hour onboard stability, with the recalling unit mandated to retain evidence of notification and customer feedback. Laboratories using the product are also advised to perform annual quality control in line with management regulations.