# China NMPA Product Recall - Creatinine assay kit (enzymatic method) and other products

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/bbf203e8-f985-492c-bd00-4c5ac16e0706/
Source feed: China

> China NMPA product recall for Creatinine assay kit (enzymatic method) and other products by Siemens Healthcare Diagnostics Inc. published November 10, 2020. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following kits: Dimension Enzymatic Creatinine Flex Reagent Cartridge (enzymatic method); Triglyceride Assay Kit (GPO-PAP method); Creatinine Assay Kit (enzymatic method); Fructose Amino Acid Assay Kit (oxidase method); Glucose Oxidase Reagents (GLUO) (oxidase method); Lactate Assay Kit (Lactate Oxidase Colorimetric Method) (LAC); Triglyceride Assay Kit (GPO-PAP method).
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2020-11-10
- Product Name: Creatinine assay kit (enzymatic method) and other products
- Recall Level: Level 3 Recall
- Recall Reason: Due to the presence of etamsylate, a coagulation agent, the analytical results of certain tests on the ADVIA biochemical analysis, Attellica CH, and Dimension platforms may show falsely decreased levels.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on November 10, 2020, for several diagnostic assay kits. Products affected include the Creatinine Assay Kit (Enzymatic Method), Triglyceride Assay Kit (GPO-PAP Method), Fructose Aminosamine Assay Kit (Oxidase Method), Glucose Oxidase Reagents (GLUO), and Lactate Reagents (LAC) Kit (Lactate Oxidase Colorimetric Method). The recall stems from the potential for these kits to produce falsely decreased analytical results when used on ADVIA biochemical analysis, Atellaca CH, and Dimension platforms. This inaccuracy is attributed to the presence of ethamsylate, a coagulation agent, within the reagents. This action falls under the regulatory framework overseen by the Shanghai Municipal Drug Administration, an arm of China's National Medical Products Administration (NMPA). The company is required to manage this recall, with comprehensive details regarding affected models, specifications, and batch numbers provided in a "Medical Device Recall Event Report Form" for stakeholders. This event highlights the critical need for accuracy in medical diagnostics and stringent quality control protocols.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/