# China NMPA Product Recall - Rubella Virus IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/cede75b7-254b-4005-875c-dcae5e5f2415/
Source feed: China

> China NMPA product recall for Rubella Virus IgM Assay Kit (Chemiluminescent Microparticle Immunoassay) by Abbott Trading (Shanghai) Co., Ltd. published December 26, 2018. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Rubella Virus IgM 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its Rubella Virus IgM Assay Kit (Chemiluminescent Microparticle Immunoassay).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2018-12-26
- Product Name: Rubella Virus IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Level: Level 3 Recall
- Recall Reason: Some kits contain incorrect components and may include two vials of project diluent (6C18J) or two vials of pretreatment solution (6C18X).
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Rubella Virus IgM Assay Kit (Chemiluminescent Microparticle Immunoassay), as reported by the National Medical Products Administration (NMPA) on December 26, 2018. This action was prompted by the discovery of incorrect components within certain product batches. Specifically, affected kits were found to potentially contain two bottles of diluent (identified as 6C18J) or two bottles of pretreatment solution (identified as 6C18X) instead of the correct configuration. The presence of these erroneous components could impact the proper functioning and reliability of the assay kit, which is used for rubella virus IgM testing. The company reported this issue and moved to remove the affected products from the market to ensure patient safety and product integrity. Detailed information regarding the specific models, specifications, and batch numbers subject to this recall is available in an accompanying "Medical Device Recall Event Report Form." This proactive measure by Abbott Trading (Shanghai) Co., Ltd. underscores their commitment to regulatory compliance under the NMPA's framework.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/