# China NMPA Product Recall - The fully automated biochemical analysis system cobas Integra 400plus, the fully automated biochemical analyzer cobas c 111/cobas c 111 with ISE

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/fcce2cdc-dbe3-4dd1-9c0a-2f2f9427a32b/
Source feed: China

> China NMPA product recall for The fully automated biochemical analysis system cobas Integra 400plus, the fully automated biochemical analyzer cobas c 111/cobas c 111 with ISE by Roche Diagnostics Products (Shanghai) Co., Ltd. published May 06, 2019. Recall level: Level 2 Recall. On May 6, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated biochemical analysis systems, fully automated biochemical analyzers, and fully automated biochemical analyzers.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-05-06
- Product Name: The fully automated biochemical analysis system cobas Integra 400plus, the fully automated biochemical analyzer cobas c 111/cobas c 111 with ISE
- Recall Level: Level 2 Recall
- Recall Reason: Insufficient recommended cleaning steps may result in contamination.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On May 6, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of several fully automated biochemical analysis systems and analyzers. This action followed an internal assessment conducted at Roche Diagnostics headquarters, which identified critical issues with the devices' recommended cleaning procedures. Specifically, the cobas integra 400plus fully automated biochemical analysis system was found to have inadequate cleaning protocols, potentially leading to contamination. Furthermore, both the cobas Integra 400plus and the cobas C111/cobas C111 with ISE fully automated biochemical analyzers faced a risk of secondary contamination when performing tests for creatinine and triglycerides, again due to insufficient cleaning procedures. The recall impacts devices with specific registration certificates, including CFDA Import Registration No. 20082401658, 20122403923, and 20162402938. The National Medical Products Administration (NMPA) published this recall, highlighting the company's proactive measure to address potential product quality and safety concerns. Affected product models, specifications, and batch details are elaborated in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product integrity under the guidance of regulatory bodies like the NMPA.

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