# China NMPA Product Recall - Urine analysis test strips (dry chemistry method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-headquarters/fc845578-962d-4c67-863c-e4dcddab18d8/
Source feed: China

> China NMPA product recall for Urine analysis test strips (dry chemistry method) by Roche Diagnostics Headquarters published July 15, 2021. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its urine 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its urine analysis test strips (dry chemistry method).
- Company Name: Roche Diagnostics Headquarters
- Publication Date: 2021-07-15
- Product Name: Urine analysis test strips (dry chemistry method)
- Recall Level: Level 2 Recall
- Recall Reason: In some cases, the interference concentrations of the urine analysis test strips (dry chemistry method) on the cobas u 601 fully automated urine analyzer deviate from the initially obtained data stated in the instruction manual. Therefore, the relevant information in the instruction manual will be updated.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Headquarters
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its urine analysis test strips (dry chemistry method) on July 15, 2021, under the regulatory framework of the National Medical Products Administration (NMPA). During internal validation experiments, Roche Diagnostics headquarters discovered a significant issue: when these test strips were utilized with the cobas u 601 fully automated urine analyzer, they exhibited interference concentrations that deviated from the data originally specified in the product's instructions for use. This discrepancy indicated a potential misrepresentation of the product's performance characteristics under certain conditions. To address this main violation, the company is undertaking two primary required actions. First, it is conducting a voluntary recall of the affected urine analysis test strips to mitigate any potential impact on users. Second, Roche Diagnostics is committed to updating the relevant content within the product's instructions for use. This critical revision will ensure that all current and future batches of the test strips accurately reflect the validated performance data, providing users with correct and up-to-date information. This proactive measure aims to uphold product quality and ensure user safety and confidence.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-headquarters/4a0bbe01-9cc2-4785-98a0-15a94f773c70/