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

Beckman Coulter Trading (China) Co., Ltd., in conjunction with manufacturer Iris Deutschland GmbH, initiated a voluntary Class III recall of its Urine Analysis Test Strips (batch number 7204081A) in late 2015. The issue, identified and reported on September 15, 2015, and subsequently published by the National Medical Products Administration (NMPA) on October 7, 2015, stemmed from a critical manufacturing defect. Specifically, the glucose test pad on the affected batch was erroneously positioned where the protein test pad should have been. This error compromised the diagnostic accuracy of the product, potentially leading to incorrect test results for critical health markers like glucose and protein. The recall affected 3400 units sold globally and within China. As required under NMPA's regulatory framework for medical device recalls, Beckman Coulter Trading (China) Co., Ltd. implemented immediate corrective actions. These included halting the shipment of all affected products to prevent further distribution and promptly informing customers to cease using the compromised test strips. This recall underscores the importance of stringent quality control in medical device manufacturing to ensure patient safety and reliable diagnostic outcomes.