# China NMPA Product Recall - Antinuclear antibody quality control products

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/0cb30a0b-36be-478a-b12a-16de69cd89c5/
Source feed: China

> China NMPA product recall for Antinuclear antibody quality control products by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published February 20, 2019. Recall level: Level 3 Recall. Bio-Life Medical Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its antinu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Ray Life Sciences (Shanghai) Co., Ltd. voluntarily recalls antinuclear antibody quality control products.
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2019-02-20
- Product Name: Antinuclear antibody quality control products
- Recall Level: Level 3 Recall
- Recall Reason: The antinuclear antibody quality control products are accompanied by a paper value sheet. Because the analyte values in the paper value sheet need to be manually entered into the system based on the test certificate results and then printed, an operator error occurred during the data entry for the aforementioned batch. The average value of the two analytes, SS-A60 and Centromere B, in the negative control product, which should have been 0.4 AI and 0.3 AI respectively, was incorrectly entered as 0.2 AI.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/bio-ray-life-sciences-shanghai-co-ltd/2e5e555e-1d88-4064-97e3-120d5825f4ca/