China NMPA Product Recall - Antinuclear antibody quality control products

Bio-Life Medical Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its antinuclear antibody quality control products (Registration Certificate No.: 20142405090) under the oversight of the National Medical Products Administration (NMPA). The recall, publicly reported on February 20, 2019, stemmed from a critical operator error during the manual data entry of analyte values from a paper value sheet into their system. Specifically, two analytes, SS-A60 and Centromere, within the negative control product, were incorrectly recorded. An error occurred where 'B' should have been an average of 0.4AI and 0.3AI, but was erroneously entered as 0.2AI. This data entry mistake led to discrepancies in the expected analyte values. The company proactively chose to recall the affected batches of products to address the quality control issue and ensure accuracy for users. Further specifics regarding the affected product types and batches are detailed in the accompanying "Medical Device Recall Event Report Form." This action highlights the importance of precise data handling in medical device manufacturing and quality assurance processes.