China NMPA Product Recall - Glycated Hemoglobin Assay Kit (High Performance Liquid Chromatography-Microcolumn Method) Afinion HbA1c

Abbott Diagnostics Technologies AS has initiated a voluntary Class III recall of its Glycated Hemoglobin (HbA1c) test kit, specifically the Afinion HbA1c (National Medical Device Registration Certificate No. 20152401837). This action, reported by Abbott Medical Diagnostics Products Ltd., was announced on September 5, 2024, by the National Medical Products Administration (NMPA). The recall stems from an issue involving incorrect product packaging. Test kits intended exclusively for sale within the United States were mistakenly distributed to Ireland. This packaging error led to the recall of the affected batches to ensure regulatory compliance and product suitability for the intended markets. Crucially, the NMPA document confirms that this specific recalled product was not imported into China, limiting the direct impact within the Chinese market, despite the publication of the recall notice by the Chinese regulatory body. Detailed information concerning the specific models, specifications, and batch numbers subject to this recall is provided in an accompanying Medical Device Recall Event Report Form.