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

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/06a95114-edf3-46dc-8201-09c05a9aa305/
Source feed: China

> China NMPA product recall for Creatinine Assay Kit (sarcosine Oxidase Method) by Abbott Trading (Shanghai) Co., Ltd. published July 14, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on July 14, 2017, that Abbott Trading 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its creatinine assay kits (sarcosine oxidase method).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Creatinine Assay Kit (sarcosine Oxidase Method)
- Recall Level: Level 3 Recall
- Recall Reason: The product in question may have performance issues, which could cause quality control results to drift and exceed acceptable limits.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on July 14, 2017, that Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Creatinine Assay Kit (Croscine Oxidase Method), identified by Registration No. 20152401999. The recall was prompted by identified performance issues where the product demonstrated a potential for quality control results to drift beyond acceptable limits. This issue raises concerns regarding the reliability and accuracy of diagnostic tests utilizing these kits. The action taken by Abbott Trading (Shanghai) Co., Ltd. is a voluntary recall to address these performance discrepancies. While the NMPA oversees such regulatory actions, the specific recall was self-reported by the company, and no direct inspection dates were provided within the document. Detailed information regarding the affected product's models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." The required action involves the systematic removal of the problematic kits from distribution and use to uphold product quality and patient safety standards under the NMPA regulatory framework.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/