China NMPA Product Recall - Creatinine assay kit (sarcosine oxidase method)

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Creatinine Assay Kit (Croscine Oxidase Method), manufactured by Sentinel CH SPA, due to performance issues that could cause quality control results to drift beyond acceptable limits. The recall report was submitted on June 8, 2017, and published by the National Medical Products Administration (NMPA) on July 27, 2017. This in vitro diagnostic product, registered under National Medical Device Registration Certificate 20152401999, is intended for the quantitative determination of creatinine in human serum, plasma, and urine. The issue affects specific batches, including 60334Y600 and 60335Y600, with varying quantities distributed in China. Under the NMPA’s regulatory framework for medical devices, Abbott Trading (Shanghai) Co., Ltd., acting as the agent, is implementing corrective actions. These actions mandate immediately informing all affected customers to discontinue use of the product, arranging for the return of the identified batches, conducting a thorough internal investigation into the root cause of the performance drift, and ensuring the destruction of all recalled products. These measures are crucial to maintain diagnostic accuracy and protect public health.