# China NMPA Product Recall - Human ABO blood typing reverse typing red blood cell kit; irregular antibody screening red blood cell reagent (indirect anti-human globulin method) ID-DiaCell I-II-III Asia

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-ray-life-sciences-shanghai-co-ltd/bef2dc9b-2054-43ab-927f-62c3b081b7e3/
Source feed: China

> China NMPA product recall for Human ABO blood typing reverse typing red blood cell kit; irregular antibody screening red blood cell reagent (indirect anti-human globulin method) ID-DiaCell I-II-III Asia by Bio-Ray Life Sciences (Shanghai) Co., Ltd. published January 18, 2021. Recall level: Level 3 Recall. Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a Class III voluntary recall of two in-vitro di

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. is voluntarily recalling its Red Blood Cell Reagent Kit for Human ABO Blood Typing Reverse and Red Blood Cell Reagent for Irregular Antibody Screening (Indirect Antiglobulin Method) ID-DiaCell I-II-III Asia.
- Company Name: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2021-01-18
- Product Name: Human ABO blood typing reverse typing red blood cell kit; irregular antibody screening red blood cell reagent (indirect anti-human globulin method) ID-DiaCell I-II-III Asia
- Recall Level: Level 3 Recall
- Recall Reason: 1. The Human ABO Blood Typing Reverse Type Red Blood Cell Reagent Kit: After loading the product into the fully automated blood typing analyzer (IH-1000), if the remaining volume of red blood cell reagent in the vial is ≤2ml, insufficient homogeneity of the red blood cell reagent may occur. This may result in a decrease in the concentration of red blood cell reagent in each test well of the blood typing card, potentially leading to a slight increase in the proportion of negative results from reverse typing. 2. The Irregular Antibody Screening Red Blood Cell Reagent (Indirect Antiglobulin Method) ID-DiaCell I-II-III Asia may experience non-specific reactions, potentially leading to a slight increase in the positive rate of anti-screening. Furthermore, after loading the product into the fully automated blood typing analyzer (IH-1000), if the remaining volume of red blood cell reagent in the vial is ≤2mL, insufficient homogeneity of the red blood cell reagent may occur, leading to a decrease in the concentration of red blood cell reagent in each test well of the blood typing card. This may result in lower-than-expected anti-screening results, or even some false negative results.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Summary: Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a Class III voluntary recall of two in-vitro diagnostic products, as reported by the National Medical Products Administration (NMPA) on January 18, 2021. The affected products include the Human ABO Blood Typing Reverse Red Blood Cell Reagent Kit and the Irregular Antibody Screening Red Blood Cell Reagent (Indirect Antiglobulin Method) ID-DiaCell I-II-III Asia. The recall addresses critical performance issues identified with both reagents. For the ABO Blood Typing Reverse Red Blood Cell Reagent Kit, when used in a fully automated analyzer, insufficient homogeneity may occur if the remaining volume is 2ml or less. This can lead to a reduced red blood cell reagent concentration in testing wells, potentially increasing mismatched positive and negative results. Similarly, the Irregular Antibody Screening Reagent may exhibit nonspecific reactions, elevating the anti-screening positivity rate. Furthermore, if its volume drops below 2ml in the analyzer, reduced homogeneity and concentration could result in lower-than-expected or even false negative anti-screening results. This voluntary action, under NMPA oversight, aims to rectify these product inconsistencies and safeguard the accuracy of blood typing and antibody screening.

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