China NMPA Product Recall - Urine analysis test strips (dry chemistry method)

The National Medical Products Administration (NMPA) announced a voluntary Class III recall by Beckman Coulter Ireland Inc., as detailed in notice JGXX-2020-10110 published on February 28, 2020. The recall specifically targets certain models and batches of the company's urine analysis test strips (dry chemistry method), registered under Certificate No. 20172402235.

The core issue necessitating this recall is a manufacturing error in which the urine glucose and urine protein pads on the test strips were found to be switched. This defect presents a significant risk for inaccurate diagnostic results, which could adversely affect patient management and treatment choices. Beckman Coulter Trading (China) Co., Ltd. proactively reported this manufacturing flaw, leading to the manufacturer's decision to voluntarily withdraw the impacted products from circulation.

Operating under the NMPA's regulatory framework, Beckman Coulter Ireland Inc. is executing this recall to rectify the quality control deficiency and uphold patient safety standards. Comprehensive information, including specific product specifications and batch numbers involved, is available in the