China NMPA Product Recall - Urea Assay Kit (Urease-Glutamate Dehydrogenase Method)

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its Urea Assay Kit (Urease-Glutamate Dehydrogenase Method), registered under Certificate Su Medical Device Registration Certificate 20172400667. This recall, reported to the National Medical Products Administration (NMPA) via the Jiangsu Provincial Drug Administration on March 20, 2020, was prompted by the company's internal confirmation that the kit's concentration continuously increases over a 30-day opening period. This inherent defect, specifically identified in batches AUZ6597, AUZ6735, and AUZ7426, can lead to calibration failure, potentially compromising the accuracy of in vitro quantitative detection results for human serum, plasma, and urine. A total of 5238 affected boxes were distributed within China. As part of the mandated corrective actions, Beckman Coulter is required to issue a "Medical Device Recall Notice" to all distributors, ensuring they inform affected customers about the necessary measures. Additionally, the company must facilitate the replacement of reagents for all recalled products. This proactive measure aims to mitigate potential risks associated with inaccurate diagnostic outcomes.