China NMPA Product Recall - Lung function instrument

Beijing Maibang Optoelectronic Instrument Co., Ltd. has initiated a voluntary Class III recall of 82 units of its Lung Function Instruments, model MSA99, following findings from an internal self-inspection. The recall was reported on July 1, 2019, and publicly announced by the National Medical Products Administration (NMPA) on July 8, 2019. The core issue identified was the company's failure to promptly update the new medical device registration certificate number on the back labels of the affected products. This labeling discrepancy falls under the regulatory oversight of the NMPA, which mandates accurate and current product information for medical devices distributed in China. To address this non-conformance, Beijing Maibang Optoelectronic Instrument Co., Ltd. is required to implement specific corrective actions. These include manufacturing new back labels that accurately display the updated registration certificate details. Additionally, the company is tasked with notifying all affected customers about the recall and ensuring the resolution of the issue by providing and applying these corrected back labels to the recalled instruments, thereby ensuring compliance with regulatory standards.