# China NMPA Product Recall - ABO forward and reverse typing and RhD blood typing reagent cards (column agglutination method); ABO/Rh blood typing retest cards (column agglutination method); Anti-human globulin (IgG) test cards (column agglutination method); Anti-human globulin (IgG, C3b/C3d) test cards

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/be7c5cc1-268e-42fb-8c68-96867f395048/
Source feed: China

> China NMPA product recall for ABO forward and reverse typing and RhD blood typing reagent cards (column agglutination method); ABO/Rh blood typing retest cards (column agglutination method); Anti-human globulin (IgG) test cards (column agglutination method); Anti-human globulin (IgG, C3b/C3d) test cards by Orsendo Medical Equipment Trading (China) Co., Ltd. published June 06, 2019. Recall level: Level 3 Recall. On June 6, 2019, Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III r

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling the following: ABO forward and reverse typing and RhD blood typing reagent cards (column agglutination method); ABO/Rh blood typing retest cards (column agglutination method); anti-human globulin (IgG) test cards (column agglutination method); and anti-human globulin (IgG, C3b/C3d) test cards.
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2019-06-06
- Product Name: ABO forward and reverse typing and RhD blood typing reagent cards (column agglutination method); ABO/Rh blood typing retest cards (column agglutination method); Anti-human globulin (IgG) test cards (column agglutination method); Anti-human globulin (IgG, C3b/C3d) test cards
- Recall Level: Level 3 Recall
- Recall Reason: Some ORTHO BioVue blood typing system test cards have malfunctioning barcode printing, causing the ORTHO AutoVue Innova fully automated blood typing and matching system, the ORTHO VISION fully automated blood typing analyzer, and/or the ORTHO VISION Max fully automated blood typing analyzer to be unable to read the barcodes on the aforementioned batches of ORTHO BioVue blood typing system test cards.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: On June 6, 2019, Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of several blood typing reagent cards. This action was reported by the Shanghai Food and Drug Administration (SFDA) under the oversight of the National Medical Products Administration (NMPA). The affected products include ABO/Rh Blood Typing Reagent Cards, ABO/Rh Blood Typing Retest Cards, Anti-human Globulin (IgG) Detection Cards, and Anti-human Globulin (IgG, C3b/C3d) Detection Cards.
The primary issue identified was abnormal barcode printing on certain ORTHO BioVue blood typing system test cards. This defect rendered the barcodes unreadable by automated analysis systems, specifically the ORTHO AutoVue Innova, ORTHO VISION, and ORTHO VISION Max. The inability of these critical systems to process the test cards poses a potential risk to the accuracy and efficiency of blood typing procedures, which are vital for patient safety in medical diagnostics.
Ausendo Medical Devices Trading (China) Co., Ltd. is undertaking this voluntary recall to address the defect and ensure the integrity of its diagnostic products. Users are directed to the "Medical Device Recall Event Report Form" for specific details on affected models, specifications, and batch numbers. This proactive measure reflects the company's commitment to product quality and regulatory compliance within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/orsendo-medical-equipment-trading-china-co-ltd/9d283785-b2ea-4291-8250-5927daf06726/