# China NMPA Product Recall - gamma-glutamyl transferase (GGT) assay kit (IFCC recommended method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-juchuang-pharmaceutical-technology-co-ltd/9b24a8a4-5428-4b20-a05d-3e6ce84f8809/
Source feed: China

> China NMPA product recall for gamma-glutamyl transferase (GGT) assay kit (IFCC recommended method) by Shanghai Juchuang Pharmaceutical Technology Co., Ltd. published August 26, 2021. Recall level: Level 3 Recall. On August 26, 2021, the National Medical Products Administration (NMPA) reported a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Juchuang Pharmaceutical Technology Co., Ltd. is voluntarily recalling its gamma-glutamyl transferase (GGT) assay kit (IFCC recommended method).
- Company Name: Shanghai Juchuang Pharmaceutical Technology Co., Ltd.
- Publication Date: 2021-08-26
- Product Name: gamma-glutamyl transferase (GGT) assay kit (IFCC recommended method)
- Recall Level: Level 3 Recall
- Recall Reason: The issue stems from the fact that the filtration equipment for reagent 1 exceeded its cleaning expiration date, causing the filtration efficiency of reagent 1 to fail to meet product requirements during production.
- Discovering Company: Shanghai Juchuang Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Shanghai Juchuang Pharmaceutical Technology Co., Ltd.
- Summary: On August 26, 2021, the National Medical Products Administration (NMPA) reported a voluntary Class III recall initiated by Shanghai Juchuang Pharmaceutical Technology Co., Ltd. This recall pertains to their Gamma-Glutamyl Transferase (GGT) Assay Kit, specifically the IFCC Recommended Method. The primary issue prompting this action was a lapse in quality control during the manufacturing process. It was discovered that the filter equipment used for Reagent 1 had exceeded its scheduled cleaning expiration date. Consequently, the filtration efficacy of Reagent 1 failed to meet the stringent product specifications, potentially compromising the kit's performance and reliability. Operating under the oversight of the NMPA, Shanghai Juchuang Pharmaceutical Technology Co., Ltd. proactively decided to retrieve the affected kits from the market. The classification of this as a Class III recall suggests that while there is a potential for adverse health consequences, the probability of serious harm is low, or the consequences are not life-threatening. The company has committed to providing comprehensive details regarding the specific product models, specifications, and batch numbers involved in the recall through a detailed "Medical Device Recall Event Report Form." This voluntary action underscores the manufacturer's responsibility to ensure product quality and patient safety within the regulatory framework established by the NMPA.

Company: https://www.globalkeysolutions.net/companies/shanghai-juchuang-pharmaceutical-technology-co-ltd/65974232-bc0e-4a16-be39-c0c741d56a9d/