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

The National Medical Products Administration (NMPA) published a document on January 10, 2018, detailing a voluntary product recall initiated by Beckman Coulter, Inc. and its affiliate, Beckman Coulter Trading (China) Co., Ltd. The recall concerns urine analysis test strips (dry chemistry method) due to a manufacturing defect. Specifically, an incorrect test strip was inadvertently placed in the compensation pad position during production. This error poses a significant risk as it could compromise the test strip's performance, potentially leading to the failure of IRISpec CB quality control. More critically, the defect has the potential to produce false negative results for all analytes tested, with the sole exception of ascorbic acid. This could have serious implications for patient diagnosis and treatment decisions. In response to this issue, Beckman Coulter, Inc. has voluntarily initiated a Class III recall for the affected urine analysis test strips, identified under Registration Certificate No.: 20172402235. The company has committed to providing detailed information regarding specific affected product models, specifications, and batch numbers in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with NMPA regulations.