China NMPA Product Recall - Creatinine Assay Kit (sarcosine Oxidase Method)

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Creatinine Assay Kit (Croscine Oxidase Method), reporting the action on June 8, 2017, with a public announcement by the National Medical Products Administration (NMPA) on July 27, 2017. The recall stemmed from identified performance issues where certain kit batches could cause quality control results to drift beyond acceptable limits. This directly impacts the accuracy of in vitro quantitative determination of creatinine in human serum, plasma, and urine. The affected kits were manufactured by Sentinel CH SPA and distributed globally, with specific quantities impacting the Chinese market. Under the NMPA's regulatory framework, Abbott implemented several required actions. These included immediate notification to all affected customers, instructing them to cease using the compromised batches and to return the products. Abbott committed to conducting an internal investigation to ascertain the root cause and implement corrective measures, ensuring that all returned products would be destroyed. This proactive recall demonstrates adherence to medical device safety standards, mitigating risks associated with potentially unreliable diagnostic tools.