# China NMPA Product Recall - Irregular Antibody Screening Red Blood Cell Kit / Human ABO Blood Typing Reverse Type Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/3b7064c5-f61a-4815-bb76-c09ec339e306/
Source feed: China

> China NMPA product recall for Irregular Antibody Screening Red Blood Cell Kit / Human ABO Blood Typing Reverse Type Kit by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published May 08, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) has publicized a voluntary Class III recall init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. is voluntarily recalling its Irregular Antibody Screening Red Blood Cell Kit/Human ABO Blood Typing Reverse Type Kit.
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Irregular Antibody Screening Red Blood Cell Kit / Human ABO Blood Typing Reverse Type Kit
- Recall Level: Level 3 Recall
- Recall Reason: Unexpected reactions may occur with the eluent and QC samples when using the "Irregular Antibody Screening Red Blood Cell Kit".
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) has publicized a voluntary Class III recall initiated by Bio-Rad Life Sciences (Shanghai) Co., Ltd. This action addresses quality control issues identified with their "Irregular Antibody Screening Red Blood Cell Reagent Kit" and, by extension, the "Human ABO Blood Typing Reverse Type Kit". Bio-Rad Life Sciences (Shanghai) Co., Ltd. reported discovering unexpected reactions when the "Irregular Antibody Screening Red Blood Cell Reagent Kit" was used in conjunction with eluent and quality control (QC) samples. This self-identified issue prompted the company's decision to recall the affected products, acknowledging a deviation from expected performance. Operating under the regulatory framework of the NMPA, Bio-Rad Life Sciences is undertaking corrective measures. While specific NMPA inspection dates are not detailed within this publication, the recall document was published on May 8, 2017. Comprehensive information regarding the specific product models, specifications, and batch numbers for the recalled items is available in the associated "Medical Device Recall Event Report Form". This recall underscores the critical importance of robust internal quality assurance processes to maintain product reliability and ensure patient safety within the medical device sector.

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