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

Instrumentation Laboratory Co., via its agent Wofen Medical Device Trading (Beijing) Co., Ltd., has initiated a voluntary Class II recall for its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method), registered under NMPA number 20152402017. The recall, reported on August 10, 2017, and published by the National Medical Products Administration (NMPA) on August 15, 2017, addresses critical performance issues identified in batch numbers N0177760 and N1166235. Customer reports indicated that some kits exhibited results exceeding established quality control limits, leading to excessively prolonged sample outcomes. These assay kits are designed for the in vitro quantitative detection of prothrombin time and fibrinogen concentration. The identified issues pose a risk to accurate diagnostic testing, impacting global regions. In response to these performance deviations, Instrumentation Laboratory Co. has mandated specific corrective actions under the NMPA's oversight. These include an immediate cessation of sales for the affected batches within China. Furthermore, all existing inventory of batch numbers N0177760 and N1166235 in China must be destroyed. The recall aims to mitigate potential diagnostic inaccuracies and ensure patient safety.