# China NMPA Product Recall - Anti-human globulin (IgG) blood typing diagnostic reagent card

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/b66eff3e-b076-41db-9321-43e284d6440e/
Source feed: China

> China NMPA product recall for Anti-human globulin (IgG) blood typing diagnostic reagent card by Ortho-Clinical Diagnostics, Inc. published June 20, 2012. Recall level: . The National Medical Products Administration (NMPA) published a report on June 20, 2012, detailing a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. is recalling its anti-human globulin (IgG) blood typing diagnostic kits.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2012-06-20
- Product Name: Anti-human globulin (IgG) blood typing diagnostic reagent card
- Recall Reason: An internal investigation has identified a defect in the manufacturing process of the plastic reagent cards that could cause intermittent drying of micropores/micropillars in the product.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) published a report on June 20, 2012, detailing a voluntary recall initiated by Ortho-Clinical Diagnostics, Inc. The recall concerned certain models of its Anti-Human Globulin (IgG) Blood Typing Test Cards, product code 707400, specifically batch numbers IGC512A and IGC513A. The primary issue identified was a manufacturing defect in the plastic test cards. This defect could lead to the intermittent drying of micropores/microcolumns within the product, potentially affecting the qualitative detection of IgG bound to red blood cell surfaces. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. was identified as the responsible unit in China for Ortho-Clinical Diagnostics, Inc. Despite the recall, the report explicitly states that no affected products from these batches were ever imported into or sold within the Chinese market, as confirmed by the May 2, 2012, recall event report. Consequently, no specific product recall actions were required in China. However, the NMPA requested that provincial Food and Drug Administrations enhance their supervision and management of similar medical devices.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/