# China NMPA Product Recall - Glucose Assay Kit (Glucose Oxidase Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/sichuan-wovent-biotechnology-co-ltd/b13d353f-4468-4f50-8e4f-ef1c5d47dd02/
Source feed: China

> China NMPA product recall for Glucose Assay Kit (Glucose Oxidase Method) by Sichuan Wovent Biotechnology Co., Ltd. published November 25, 2019. Recall level: Level 3 Recall. Sichuan Wovente Biotechnology Co., Ltd. has initiated a voluntary Class III recall of its Glucose As

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Sichuan Wovente Biotechnology Co., Ltd. is voluntarily recalling its glucose assay kits (glucose oxidase method).
- Company Name: Sichuan Wovent Biotechnology Co., Ltd.
- Publication Date: 2019-11-25
- Product Name: Glucose Assay Kit (Glucose Oxidase Method)
- Recall Level: Level 3 Recall
- Recall Reason: The product in question failed the national supervision and spot check in 2019 because the tested items did not meet the technical requirements for medical device products specified in Sichuan Medical Device Registration Certificate No. 20162400011, "Glucose Assay Kit (Glucose Oxidase Method)".
- Discovering Company: Sichuan Wovent Biotechnology Co., Ltd.
- Manufacturing Company: Sichuan Wovent Biotechnology Co., Ltd.
- Summary: Sichuan Wovente Biotechnology Co., Ltd. has initiated a voluntary Class III recall of its Glucose Assay Kit (Glucose Oxidase Method) due to findings from a 2019 national supervision and spot check. The recall was announced by the National Medical Products Administration (NMPA) on November 25, 2019. The main issue identified was that the product, registered under code Sichuan Medical Device Registration 20162400011, failed to meet the specified technical requirements for medical devices. This non-compliance was discovered during routine regulatory oversight. As a result, Sichuan Wovente Biotechnology Co., Ltd. is required to remove the affected batches of the Glucose Assay Kit from the market. The specific models, specifications, and batch numbers involved in the recall are detailed in the accompanying "Medical Device Recall Event Report Form." This action underscores the NMPA's commitment to ensuring product quality and safety within the medical device industry, upholding rigorous standards for diagnostic tools like the Glucose Assay Kit.

Company: https://www.globalkeysolutions.net/companies/sichuan-wovent-biotechnology-co-ltd/fb8c8507-16fc-4f8b-9dd4-3ed7c770b9bf/