China NMPA Product Recall - Fully automated urine formed elements analyzer

On August 20, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Kobo Smart Medical Technology (Shanghai) Co., Ltd. The recall targets their fully automated urine formed element analyzer, identified by Registration Certificate No.: 沪械注准20202220371. The primary reason for this action is the discovery of incorrect product labeling information associated with the device. This recall falls under the regulatory purview of the NMPA, with the announcement originating from the Shanghai Municipal Drug Administration Website.

As a required action, Kobo Smart Medical Technology (Shanghai) Co., Ltd. is undertaking this voluntary recall to rectify the labeling discrepancies and ensure compliance with medical device regulations. The Class III classification signifies that the identified issue, while requiring attention, is unlikely to cause adverse health consequences. Detailed information concerning the specific models, specifications, and affected batch numbers of the analyzers is documented in the "Medical Device Recall Event Report Form," which stakeholders can access. This incident underscores the critical importance of accurate product information in the medical device sector and the robust regulatory framework established by the NMPA to oversee product quality and safety, ensuring manufacturers promptly address any non-conformities. The company's voluntary action demonstrates its commitment to upholding regulatory standards and ensuring the reliability of its medical devices.