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

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its urine analysis test strips (dry chemistry method) on July 15, 2021, under the regulatory framework of the National Medical Products Administration (NMPA). During internal validation experiments, Roche Diagnostics headquarters discovered a significant issue: when these test strips were utilized with the cobas u 601 fully automated urine analyzer, they exhibited interference concentrations that deviated from the data originally specified in the product's instructions for use. This discrepancy indicated a potential misrepresentation of the product's performance characteristics under certain conditions. To address this main violation, the company is undertaking two primary required actions. First, it is conducting a voluntary recall of the affected urine analysis test strips to mitigate any potential impact on users. Second, Roche Diagnostics is committed to updating the relevant content within the product's instructions for use. This critical revision will ensure that all current and future batches of the test strips accurately reflect the validated performance data, providing users with correct and up-to-date information. This proactive measure aims to uphold product quality and ensure user safety and confidence.