China NMPA Product Recall - Alpha-fetoprotein and its isoform ratio assay kit (immunofluorescence assay)

On July 16, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Fujifilm and Koko Pure (Shanghai) Chemical Co., Ltd. The recall involves their Alpha-Fetoprotein and Isoform Ratio Assay Kit (Immunofluorescence Method), with Registration Certificate No. 20163402601. The core issue arose during a renewal registration process, as the product was initially registered prior to the 2014 regulatory updates. The updated label layout, intended to reflect both the medical device registration certificate number and product technical requirements number, inadvertently omitted the mandatory "National Medical Device Registration Certificate" text from the registration certificate number. This labeling oversight represents a regulatory non-compliance within the NMPA's framework. Fujifilm and Koko Pure proactively initiated this recall to correct the discrepancy and ensure all product labeling adheres to current regulatory standards. Detailed information on affected models, specifications, and batches is provided in the associated Medical Device Recall Event Report Form.