# China NMPA Product Recall - Immunoglobulin M assay kit (immunoturbidimetric method); Transferrin assay kit (immunoturbidimetric method); Haptoglobulin assay kit (immunoturbidimetric method); Lipoprotein A1 assay kit (immunoturbidimetric method); Apolipoprotein B assay kit (immunoturbidimetric method); Complement C3 assay kit (immunoturbidimetric method); Complement C4 assay kit (immunoturbidimetric method); Immunoglobulin A assay kit (immunoturbidimetric method); Immunoglobulin G assay kit (immunoturbidimetric method)

Source: https://www.keypedia.com/records/china_product_recall/abbott-trading-shanghai-co-ltd/c558d9d8-8963-4f96-a9c4-57c9aa1a6368
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> China NMPA product recall for Immunoglobulin M assay kit (immunoturbidimetric method); Transferrin assay kit (immunoturbidimetric method); Haptoglobulin assay kit (immunoturbidimetric method); Lipoprotein A1 assay kit (immunoturbidimetric method); Apolipoprotein B assay kit (immunoturbidimetric method); Complement C3 assay kit (immunoturbidimetric method); Complement C4 assay kit (immunoturbidimetric method); Immunoglobulin A assay kit (immunoturbidimetric method); Immunoglobulin G assay kit (immunoturbidimetric method) by Abbott Trading (Shanghai) Co., Ltd. published May 24, 2019. Recall level: Level 2 Recall. On May 24, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for multi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling the following kits: Immunoglobulin M Assay Kit (Immunoturbidimetric Method); Transferrin Assay Kit (Immunoturbidimetric Method); Haptoglobulin Assay Kit (Immunoturbidimetric Method); Apolipoprotein A1 Assay Kit (Immunoturbidimetric Method); Apolipoprotein B Assay Kit (Immunoturbidimetric Method); Complement C3 Assay Kit (Immunoturbidimetric Method); Complement C4 Assay Kit (Immunoturbidimetric Method); Immunoglobulin A Assay Kit (Immunoturbidimetric Method); Immunoglobulin G Assay Kit (Immunoturbidimetric Method).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-05-24
- Product Name: Immunoglobulin M assay kit (immunoturbidimetric method); Transferrin assay kit (immunoturbidimetric method); Haptoglobulin assay kit (immunoturbidimetric method); Lipoprotein A1 assay kit (immunoturbidimetric method); Apolipoprotein B assay kit (immunoturbidimetric method); Complement C3 assay kit (immunoturbidimetric method); Complement C4 assay kit (immunoturbidimetric method); Immunoglobulin A assay kit (immunoturbidimetric method); Immunoglobulin G assay kit (immunoturbidimetric method)
- Recall Level: Level 2 Recall
- Recall Reason: Issues related to revising the Chinese instruction manual for the product.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: On May 24, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for multiple Immunoturbidimetric Assay Kits. This action, reported to the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses product-related issues and necessary revisions to the Chinese instruction manuals for these registered medical devices. The recall encompasses several diagnostic kits, including Immunoglobulin M, Transferrin, Haptoglobulin, Apolipoprotein A1, Apolipoprotein B, Complement C3, Complement C4, Immunoglobulin A, and Immunoglobulin G Assay Kits, all holding specific NMPA registration certificates. While the precise nature of the 'product-related issues' is not detailed in this announcement, the requirement for instruction manual revisions suggests concerns pertaining to product information or usage guidance. Abbott Trading (Shanghai) Co., Ltd. is responsible for implementing this recall, with specific details on affected batches and models contained within the referenced Medical Device Recall Event Report Form.

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