# China NMPA Product Recall - Red blood cell reagent for irregular antibody screening

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/30b4ad8c-4cdf-4acc-85d3-6dd63d20bee0/
Source feed: China

> China NMPA product recall for Red blood cell reagent for irregular antibody screening by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published May 30, 2019. Recall level: Level 3 Recall. On May 30, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. is voluntarily recalling its red blood cell reagent for irregular antibody screening.
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2019-05-30
- Product Name: Red blood cell reagent for irregular antibody screening
- Recall Level: Level 3 Recall
- Recall Reason: Two batches (45330521 and 45330522) of the erythrocyte reagent for irregular antibody screening may exhibit a weakened response to samples containing Mia antibodies, leading to false negative results.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: On May 30, 2019, Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its irregular antibody screening red blood cell reagent. This action, overseen by the National Medical Products Administration (NMPA) and referencing NMPA Index No. JGXX-2019-10347, addressed a significant product issue. Specifically, two batches of the reagent, identified by numbers 45330521 and 45330522, were found to potentially exhibit a weakened reaction when encountering samples containing Mia antibodies. This defect is critical as it carries the risk of producing false negative results during patient screenings. The company's Medical Device Registration Certificate No. is 20153402292. The regulatory framework for this action involves both the NMPA and the Shanghai Food and Drug Administration. The primary issue concerns the compromised reliability of a diagnostic tool vital for identifying specific antibodies, which could have serious implications for patient safety, particularly in blood transfusion contexts. As a required action, Bio-Rad Life Sciences (Shanghai) Co., Ltd. is systematically recalling the affected products, with detailed information on models and specifications provided in the associated Medical Device Recall Event Report Form. The Class III classification suggests that the identified issue may cause adverse health consequences that are unlikely to be life-threatening.

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