# 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/eaba4943-64f0-4ee9-9088-ea11f87da2f5/
Source feed: China

> China NMPA product recall for Antinuclear antibody quality control products by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published February 14, 2019. Recall level: Level 3 Recall. Bio-Life Medical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its antinuc

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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: 2019-02-14
- Product Name: Antinuclear antibody quality control products
- Recall Level: Level 3 Recall
- Recall Reason: In the paper value assignment table accompanying the antinuclear antibody quality control product, due to an operator's input error, the average value of the two analytes SS-A 60 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 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.

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