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

Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary Class III recall of its Urine Analysis Test Strips (Dry Chemistry Method). The recall, publicized by the National Medical Products Administration (NMPA) on December 5, 2018, and referenced by the Shanghai Food and Drug Administration, addresses a critical product issue. The company identified an increased sensitivity in the urobilinogen reaction of the test strips, which carries the risk of producing erroneously elevated urobilinogen results. This defect could potentially lead to inaccurate patient diagnoses or treatment decisions. The company's proactive measure to recall the product (Registration Certificate No.: 20172402235) demonstrates its commitment to product safety and compliance with regulatory standards. Detailed information regarding the specific models, specifications, and affected batches is available in the associated "Medical Device Recall Event Report Form." This action ensures the removal of potentially faulty devices from the market to protect public health.