China NMPA Product Recall - Fructose-Aminosamine Assay Kit (Oxidase Method)

On September 24, 2020, Siemens Healthcare Diagnostics initiated a voluntary Class III recall of its Fructosamine Assay Kits (Oxidase Method). The recall was reported by Siemens Healthcare Diagnostics (Shanghai) Co., Ltd. and published by the National Medical Products Administration (NMPA), with information sourced from the Shanghai Municipal Drug Administration. The decision for the recall stemmed from a confirmed issue where quality control results for certain batches of the fructosamine assay kits demonstrated a positive bias. This discrepancy was observed when comparing the quality control results against patient sample results, specifically in relation to a comparison method outlined in the kit's instructions. This positive bias implies a potential for inaccurate diagnostic measurements, which could impact patient care. A Class III recall signifies that use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information regarding the specific affected product models, specifications, and batch numbers is available in an accompanying "Medical Device Recall Event Report Form." Siemens Healthcare Diagnostics is taking action to address this quality concern to ensure product reliability.