# China NMPA Product Recall - Human ABO blood typing reverse typing uses a 0.8% erythrocyte reagent kit (column agglutination method); human ABO blood typing reverse typing uses a 3% erythrocyte reagent kit (column agglutination method); human irregular antibody detection uses a 3% erythrocyte reagent kit (column agglutination method).

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-tc2016-196/998b532a-e211-4878-bbbc-07394c6318e0/
Source feed: China

> China NMPA product recall for Human ABO blood typing reverse typing uses a 0.8% erythrocyte reagent kit (column agglutination method); human ABO blood typing reverse typing uses a 3% erythrocyte reagent kit (column agglutination method); human irregular antibody detection uses a 3% erythrocyte reagent kit (column agglutination method). by Ortho-Clinical Diagnostics (TC2016-196) published December 29, 2016. Recall level: Level II. Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnost

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its 0.8% Red Blood Cell Reagent Kit (Column Agglutination Method) for Human ABO Blood Typing Reverse Type, 3% Red Blood Cell Reagent Kit (Column Agglutination Method) for Human ABO Blood Typing Reverse Type, and 3% Red Blood Cell Reagent Kit (Column Agglutination Method) for Human Irregular Antibody Detection.
- Company Name: Ortho-Clinical Diagnostics (TC2016-196)
- Publication Date: 2016-12-29
- Product Name: Human ABO blood typing reverse typing uses a 0.8% erythrocyte reagent kit (column agglutination method); human ABO blood typing reverse typing uses a 3% erythrocyte reagent kit (column agglutination method); human irregular antibody detection uses a 3% erythrocyte reagent kit (column agglutination method).
- Recall Level: Level II
- Recall Reason: Ortho discovered that due to microbial contamination of some raw materials, which may affect specific batches of reagent products, significant hemolysis may occur in red blood cell products (RRBC) and quality control products containing red blood cells. If significantly hemolyzed red blood cell products are used in testing, false positive or false negative results may be generated, potentially harming patients.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (TC2016-196)
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnostics, initiated a voluntary Class II recall for specific batches of its 0.8% and 3% Red Blood Cell Reagent Kits for Human ABO Blood Typing and 3% Red Blood Cell Reagent Kit for Human Irregular Antibody Detection (Column Agglutination Method). This recall was reported on November 22, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016. The core issue identified was microbial contamination of certain raw materials, which could lead to significant hemolysis in the red blood cell reagent products. If used in testing, these affected reagents had the potential to generate incorrect results, including false positives or false negatives, thereby posing a risk of harm to patients. Although the recall was initiated globally, a diagnostic investigation revealed that products marketed and sold within China did not exhibit hemolysis during customer acceptance or use. Furthermore, the company received no complaints regarding hemolysis for products distributed in China, and relevant batches had largely been consumed. Consequently, Ausendo Medical Devices Trading (China) Co., Ltd. reported the event to the Shanghai Food and Drug Administration but took no further on-site actions in China. The company did not submit subsequent recall implementation reports, investigation reports, or summary reports for the China market, as the significant hemolysis incident did not affect products sold domestically.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-tc2016-196/3fce0c14-c724-4647-a932-593127fb93e8/