China NMPA Product Recall - Antinuclear antibody quality control products

Bio-Life Medical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its antinuclear antibody quality control products (Registration Certificate No.: 20142405090), as reported to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on February 14, 2019. The recall resulted from an operator error during the manual entry of analyte values for the product. Specifically, the paper value sheet for the negative control product contained incorrect entries for two analytes, SS-A 60 and Centromere B. These should have been an average of 0.4AI and 0.3AI, respectively, but were erroneously entered as 0.2AI. This data entry mistake led to inaccurate product information. The company is proactively addressing this issue by recalling affected batches, demonstrating its commitment to product quality and data accuracy under the NMPA's regulatory framework. Further details on specific models, specifications, and batches are provided in the Medical Device Recall Event Report Form.