# China NMPA Product Recall - Blood glucose meter (product name: Fulishan Yuejie type)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-diabetes-care-ltd/5594bf77-1976-4354-ad04-1721b9efe756/
Source feed: China

> China NMPA product recall for Blood glucose meter (product name: Fulishan Yuejie type) by Abbott Diabetes Care Ltd. published July 06, 2016. Recall level: Level III. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for 372 units of its Free

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its blood glucose meter (product name: Fulisin Viva).
- Company Name: Abbott Diabetes Care Ltd.
- Publication Date: 2016-07-06
- Product Name: Blood glucose meter (product name: Fulishan Yuejie type)
- Recall Level: Level III
- Recall Reason: Some blood glucose meters have labels with incorrect registration certificate numbers. The error is that the medical device registration certificate number uses an old approval number.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Diabetes Care Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for 372 units of its FreeStyle Freedom Lite blood glucose meters in China. The recall, reported on May 23, 2016, and published by the National Medical Products Administration (NMPA) on July 6, 2016, was prompted by an labeling error. Specifically, the medical device registration certificate numbers on some product labels were incorrect, displaying an outdated approval number. While the issue was purely administrative and did not pose a safety risk, Abbott Diabetes Care Ltd. acted proactively under the NMPA's regulatory framework. The company contacted affected users, offering free replacements for their blood glucose meters. Users had the option to receive a new, correctly labeled FreeStyle Freedom Lite meter, with instructions to discard their old device, or to continue using their existing meters if preferred. Replaced meters were affixed with a "Not for Sale" mark.

Company: https://www.globalkeysolutions.net/companies/abbott-diabetes-care-ltd/cc520213-e4f2-4f6d-82fd-c470b98a244b/