China NMPA Product Recall - Magnesium Assay Kit (Xyleneamine Blue Method)

On December 13, 2021, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Magnesium Assay Kit (Xyleneamine Blue Method), identified by Registration Certificate No.: 20142405732. This action was reported to the National Medical Products Administration (NMPA). The recall stems from internal interference testing conducted as part of an in vitro diagnostic medical device regulation (IVDR) remedial project, adhering to CLSI Guideline EP07 Version 3. The company discovered that the assay kit failed to meet the specified serum application lipemia interference quality standard outlined in its instructions for use. Specifically, the kit's performance exceeded the acceptable interference limit of less than 10% at a fat emulsion concentration up to 500 mg/dL. Testing revealed significant biases: a low-level analyte sample pool (0.82 mmol/L) showed a maximum bias of +30.38%, and a high-level sample pool (2.06 mmol/L) showed a maximum bias of +13.56%. Beckman Coulter Trading (China) Co., Ltd. is taking required actions by voluntarily recalling the affected product. Further details on specific models, specifications, and batch numbers are available in the associated Medical Device Recall Event Report Form.