# China NMPA Product Recall - Glucose, lactic acid, and urea electrode boxes

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/69d2a93e-b75d-42d5-b7cd-b6d167fd7b98/
Source feed: China

> China NMPA product recall for Glucose, lactic acid, and urea electrode boxes by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 14, 2017. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its glucos

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling glucose, lactate, and urea electrode kits.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Glucose, lactic acid, and urea electrode boxes
- Recall Level: Level 2 Recall
- Recall Reason: Software issues with the product may affect urea level test results.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its glucose, lactic acid, and urea electrode kits (Registration No. 20142403745). The recall, publicly reported on July 14, 2017, was prompted by the discovery of a software issue within the product. This identified defect has the potential to compromise the accuracy of urea value detection results, which are critical for diagnostic purposes. While specific inspection dates are not detailed in the announcement, the company's prompt action reflects its commitment to product safety. The recall, overseen by the National Medical Products Administration (NMPA), requires the company to remove the affected kits from distribution to safeguard patient safety and ensure the reliability of diagnostic testing. Detailed information regarding the specific models, specifications, and batch numbers of the impacted products is available in the associated "Medical Device Recall Event Report Form" attachments. This proactive measure underscores the company's responsibility in maintaining high product quality under the regulatory framework of the NMPA.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/