# China NMPA Product Recall - Gamma-Glutamyl Transferase Reagents (GGT) Assay Kit (Rate Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/8ad9bfed-40a2-4105-a38a-9de2063ab4eb/
Source feed: China

> China NMPA product recall for Gamma-Glutamyl Transferase Reagents (GGT) Assay Kit (Rate Method) by Siemens Healthcare Diagnostics Inc. published December 01, 2020. Recall level: Level 3 Recall. On December 1, 2020, the National Medical Products Administration (NMPA) and the Shanghai Municipal 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Gamma-Glutamyl Transferase Reagents (GGT) kits (rate method).
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2020-12-01
- Product Name: Gamma-Glutamyl Transferase Reagents (GGT) Assay Kit (Rate Method)
- Recall Level: Level 3 Recall
- Recall Reason: The gamma-glutamyl transferase assay kit (rate method) (GGT) may exhibit a coefficient of variation (%CV) exceeding the repeatability (intra-assay) performance data listed in the instructions for use on some biochemical analyzers. This increased imprecision only occurs at low concentrations of approximately 27-42 U/L. The imprecision observed at these low concentrations does not affect the average recovery of the quality control material.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: On December 1, 2020, the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration reported a voluntary Class III product recall initiated by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., also referred to as Siemens Healthcare Diagnostics Inc. The recall concerns their Gamma-Glutamyl Transferase Reagents (GGT) Kit (Rate Method), specifically product with Registration Certificate No.: 20172401020. The primary issue identified was that the GGT assay kit exhibited a coefficient of variation (%CV) exceeding the specified repeatability performance data. This increased imprecision was observed only at low GGT concentrations, approximately between 27-42 U/L, when used with certain biochemical analyzers. It was clarified that this imprecision at low concentrations did not impact the average recovery rate of quality control materials, indicating a specific performance anomaly rather than a widespread measurement failure across all concentration ranges. In response to this identified performance deviation, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall. This classification typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. The company's required action involves retrieving the affected batches of the GGT assay kits to address the documented imprecision. Detailed information regarding the specific models, specifications, and batch numbers of the recalled products is available in the accompanying Medical Device Recall Event Report Form.

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