China NMPA Product Recall - Creatinine assay kit (enzymatic method) CR-E (Creatinine); Uric acid assay kit (colorimetric method)

On August 30, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a Class III voluntary recall of its Creatinine Assay Kit (Enzymatic Method) CR-E and Uric Acid Assay Kit (Colorimetric Method). This action was taken in response to a critical issue identified with the products. The main concern is that N-acetyl-p-benzoquinone imine (NAPQI), a metabolite produced from an acetaminophen (paracetamol) overdose, can significantly interfere with the enzymatic detection methods used in these kits. Specifically, high concentrations of NAPQI in serum can negatively impact the accuracy of both creatinine and uric acid measurements, potentially leading to incorrect diagnostic results. The recall was reported by the Shanghai Food and Drug Administration, operating under the oversight of the National Medical Products Administration (NMPA). The company proactively initiated this recall to address the identified product sensitivity to acetaminophen metabolites. Detailed information regarding the specific affected product models, specifications, and batch numbers is available in the associated 'Medical Device Recall Event Report Form'. This voluntary recall underscores the company's commitment to patient safety and product reliability within the regulatory framework established by the NMPA.