China NMPA Product Recall - Immunoassay Analyzer

Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its immunoassay analyzers (Registration Certificate No.: CFDA 2014 No. 2403526). This action was officially announced on December 5, 2018, under the regulatory authority of the National Medical Products Administration (NMPA) and specifically referenced by the Shanghai Food and Drug Administration (Medical Device Recall 2018-267). The primary issue leading to the recall was an identified error in the printing of the production date on the product labels of the affected devices. While the document does not specify inspection dates, the recall reflects the company's response to this critical labeling inaccuracy. As a Class III recall, this classification indicates that the product defect is unlikely to cause adverse health consequences. Radomet Medical Equipment (Shanghai) Co., Ltd. is responsible for implementing the recall, with comprehensive details regarding affected models, specifications, and batch numbers provided in the accompanying "Medical Device Recall Event Report Form." This proactive measure ensures adherence to medical device regulations by rectifying the labeling discrepancy.