# China NMPA Product Recall - Estradiol Assay Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/79af6aef-56bf-409e-afe6-07a704bfac56/
Source feed: China

> China NMPA product recall for Estradiol Assay Kit (Chemiluminescent Microparticle Immunoassay) by Abbott Trading (Shanghai) Co., Ltd. published February 18, 2019. Recall level: Level 2 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a Class II voluntary recall of its Estradiol Assay Kit

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its estradiol assay kit (chemiluminescent microparticle immunoassay).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-02-18
- Product Name: Estradiol Assay Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Level: Level 2 Recall
- Recall Reason: The drug mifepristone may interfere with estradiol testing, leading to falsely elevated estradiol results.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a Class II voluntary recall of its Estradiol Assay Kit (Chemiluminescent Microparticle Immunoassay) on February 18, 2019. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, as indicated by the product's registration certificate. The primary issue identified was a potential interference from the drug mifepristone, which could lead to falsely elevated estradiol test results when using the affected kit. This poses a risk of inaccurate diagnoses or treatment decisions based on misleading laboratory findings. Abbott Trading (Shanghai) Co., Ltd. reported this issue and commenced the recall to address the product's quality and reliability concerns. The company provided a 'Medical Device Recall Event Report Form' with detailed information on the specific models, specifications, and batch numbers of the affected products. This voluntary recall demonstrates the company's responsibility to mitigate potential health risks associated with its medical devices and ensure product safety in the market.

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