# China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/68787ed3-4fe3-4713-9dbd-6287ef093cda/
Source feed: China

> China NMPA product recall for Fully automated chemiluminescence immunoassay analyzer by Abbott Trading (Shanghai) Co., Ltd. published January 02, 2019. Recall level: Level 3 Recall. On January 2, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its fully automated chemiluminescence immunoassay analyzer.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-01-02
- Product Name: Fully automated chemiluminescence immunoassay analyzer
- Recall Level: Level 3 Recall
- Recall Reason: The products in question may cause issues such as foaming/bubbling or unexpected buffer crystallization on the outside of the concentrated cleaning buffer reservoir.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: On January 2, 2019, Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its fully automated chemiluminescence immunoassay analyzer. This action was prompted by potential issues identified with the device, specifically foaming or bubbling, and unexpected crystallization of buffer on the exterior of the concentrated cleaning buffer reservoir. The affected product, registered under certificate No. 20183400031, necessitates this recall to address the quality concerns. Overseen by the National Medical Products Administration (NMPA), this voluntary recall highlights the company's responsibility to manage product safety under the regulatory framework. While no specific inspection dates were provided in the recall announcement, the company's proactive measure aligns with regulatory expectations. Abbott Trading (Shanghai) Co., Ltd. is required to furnish comprehensive details regarding the specific models, specifications, and batch numbers of the affected products, which are available in the associated "Medical Device Recall Event Report Form" for stakeholders and affected parties. The company is taking the necessary steps to address the identified product deficiencies and manage the recall effectively in accordance with NMPA guidelines.

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