China NMPA Product Recall - Calcium assay kit (Azoma III method)

On October 11, 2016, Zhangjiakou Aopsen Technology Development Co., Ltd. initiated a Level III voluntary recall for its Calcium Assay Kit (Azoarsine III), batch number 20160310. This action followed a 2016 National Medical Device Supervision and Inspection, which determined that the product failed to meet its established registration standard requirements. The kit is designed for in vitro quantitative determination of calcium in human serum and plasma. The recall impacts specific health centers and hospitals in Inner Mongolia, Hebei Province, and Beijing. Out of 20 boxes produced for batch 20160310, five boxes had been sold within China. Under the oversight of the National Medical Products Administration (NMPA) and the Zhangjiakou Municipal Food and Drug Administration, Zhangjiakou Aopsen Technology Development Co., Ltd. was required to take several immediate actions. These included halting sales of all existing inventory, notifying users, and recalling already distributed products. Furthermore, the company was mandated to report the recall to the Zhangjiakou Municipal Food and Drug Administration and conduct an internal analysis to identify the root causes of the non-compliance, subsequently implementing corrective measures.