# China NMPA Product Recall - Anti-human globulin (IgG, C3b/C3d) test card

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/32511e23-f923-44b6-b07b-0672e16159f3/
Source feed: China

> China NMPA product recall for Anti-human globulin (IgG, C3b/C3d) test card by Orsendo Medical Equipment Trading (China) Co., Ltd. published December 18, 2020. Recall level: Level 3. Ortho Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of its anti-h

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ausendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its anti-human globulin (IgG, C3b/C3d) test cards.
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2020-12-18
- Product Name: Anti-human globulin (IgG, C3b/C3d) test card
- Recall Level: Level 3
- Recall Reason: The products in question are those used on the ORTHO VISION and ORTHO VISION Max automated blood typing analyzers and the Ortho AutoVue automated blood typing and matching system. Customers reported results of 0.5+ or Indeterminate (IND) for processing patient or quality control (QC) samples, even though a negative result was expected.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: Ortho Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of its anti-human globulin (IgG, C3b/C3d) test cards. This recall was reported to the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, as detailed in a December 18, 2020, publication. The primary issue stemmed from customer reports indicating incorrect results (0.5+ or Indeterminate) when the test cards were used with ORTHO VISION, ORTHO VISION Max, and Ortho AutoVue fully automated blood typing analyzers. These erroneous readings occurred with both patient and quality control samples, where a negative result was anticipated. The company proactively reported the incident and is executing the recall to address the product's performance discrepancy. Further specific details regarding affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form" referenced in the official announcement.

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