# China NMPA Product Recall - ABO/Rh forward and reverse blood typing reagent cards

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/a4f7b4d0-002b-456c-b173-7bb60209f486/
Source feed: China

> China NMPA product recall for ABO/Rh forward and reverse blood typing reagent cards by Ortho-Clinical Diagnostics, Inc. published June 20, 2012. Recall level: . The National Medical Products Administration (NMPA) issued a report on June 20, 2012, concerning a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. is recalling its ABO/Rh forward and reverse typing test cards.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2012-06-20
- Product Name: ABO/Rh forward and reverse blood typing reagent cards
- Recall Reason: A manufacturing defect in the plastic reagent cards can 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) issued a report on June 20, 2012, concerning a voluntary global recall initiated by Ortho-Clinical Diagnostics, Inc. for specific ABO/Rh forward and reverse typing test cards. This action was prompted by an internal investigation confirming a manufacturing defect in the plastic reagent cards. The issue involves the intermittent drying of micropores/micropillars, which could compromise the product's efficacy in its intended use for in vitro diagnosis of human erythrocyte antigens and antibodies. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., representing Ortho-Clinical Diagnostics in China, confirmed that the affected product batches (e.g., ABR886A) were never imported into or sold within the Chinese market. Therefore, no product retrieval or specific recall implementation is required in China. The NMPA's regulatory framework dictates that it informs and directs provincial food and drug administrations to maintain supervision over such products, even when there is no direct market impact. This ensures continued vigilance over medical device safety and compliance, emphasizing the NMPA's oversight role despite the lack of affected products in the Chinese market.

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