China NMPA Product Recall - Test card
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Radomet Medical Devices (Shanghai) Co., Ltd. has initiated a voluntary Level III recall of specific test cards due to a significant error in the printing of the production date on the outer packaging. This action was reported to and is overseen by the National Medical Products Administration (NMPA) of China, operating within its regulatory framework for medical devices. The affected products include test cards identified under Registration Certificate No. 国食药监械(进)字2014第2403270号. While precise models, specifications, and batch numbers are detailed in a separate Medical Device Recall Event Report Form, the core issue relates to this critical labeling inaccuracy. The company's proactive recall underscores its commitment to maintaining product integrity and ensuring patient safety by addressing potential confusion or misuse arising from incorrect dating information. This swift response aligns with regulatory expectations for manufacturers to manage and rectify product deficiencies in the medical device sector.
ID · 70c15f6a-97e9-4d8a-926b-45014887050c