# China NMPA Product Recall - Cell counting chamber cobas u cuvette

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/cee0a2e8-4f43-4e0c-ae2d-92ed26c6880f/
Source feed: China

> China NMPA product recall for Cell counting chamber cobas u cuvette by Roche Diagnostics Products (Shanghai) Co., Ltd. published February 10, 2021. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its Cobas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary recall of its Cobas u Cuvette cell counting chamber.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-02-10
- Product Name: Cell counting chamber cobas u cuvette
- Recall Level: Level 3 Recall
- Recall Reason: The production date was printed incorrectly on the English label of some batches of cell counting kits.
- 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 Level III recall for its Cobas U Cuvette cell counting kits, registered under certificate number 20192220617. This action, publicly reported on February 26, 2021, and detailed in a recall event form dated February 10, 2021, follows an internal investigation conducted by Roche Diagnostics headquarters. The investigation identified a significant labeling error: an incorrect production date was printed on the English labels of certain affected batches of the cell counting kits. The company proactively reported this finding to the Shanghai Municipal Drug Administration, demonstrating adherence to regulatory expectations for medical device manufacturers in China. A Level III recall, while generally indicating that the product defect is not expected to cause serious adverse health consequences, is nonetheless essential for maintaining product integrity and user confidence. Accurate labeling, especially concerning critical information like production dates, is fundamental for proper inventory management, traceability, and ensuring the timely use of diagnostic products. Roche Diagnostics Products (Shanghai) Co., Ltd. is taking necessary steps to address this discrepancy, with comprehensive details on the specific models, specifications, and affected batch numbers available in the official recall report.

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