# China NMPA Product Recall - Sodium electrode conditioning solution for electrolyte detection; calibrators for blood gas and hemoglobin module detection; quality control products for electrolyte detection; calibrators for blood gas and electrolyte detection; reagent kits for blood gas and electrolyte detection; calibrators for blood gas and electrolyte detection; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas and electrolyte detection (Level 1); multiple quality control products for blood gas and electrolyte detection (Level 2); multiple quality control products for blood gas and electrolyte detection (Level 3); multiple quality control products for blood gas, electrolyte, and biochemical analysis.

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/c687f1d4-56f5-41cb-81af-8776b0a6f234/
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> China NMPA product recall for Sodium electrode conditioning solution for electrolyte detection; calibrators for blood gas and hemoglobin module detection; quality control products for electrolyte detection; calibrators for blood gas and electrolyte detection; reagent kits for blood gas and electrolyte detection; calibrators for blood gas and electrolyte detection; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas and electrolyte detection (Level 1); multiple quality control products for blood gas and electrolyte detection (Level 2); multiple quality control products for blood gas and electrolyte detection (Level 3); multiple quality control products for blood gas, electrolyte, and biochemical analysis. by Roche Diagnostics Products (Shanghai) Co., Ltd. published March 22, 2019. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for several d

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following products: sodium electrode conditioning solution for electrolyte testing; calibrators for blood gas and hemoglobin module testing; quality control products for electrolyte testing; calibrators for blood gas and electrolyte testing; reagent kits for blood gas and electrolyte testing; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas and electrolyte testing (level 1); multiple quality control products for blood gas and electrolyte testing (level 2); multiple quality control products for blood gas and electrolyte testing (level 3); and multiple quality control products for blood gas, electrolyte, and biochemical analysis.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-03-22
- Product Name: Sodium electrode conditioning solution for electrolyte detection; calibrators for blood gas and hemoglobin module detection; quality control products for electrolyte detection; calibrators for blood gas and electrolyte detection; reagent kits for blood gas and electrolyte detection; calibrators for blood gas and electrolyte detection; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas, electrolyte, and biochemical analysis; multiple quality control products for blood gas and electrolyte detection (Level 1); multiple quality control products for blood gas and electrolyte detection (Level 2); multiple quality control products for blood gas and electrolyte detection (Level 3); multiple quality control products for blood gas, electrolyte, and biochemical analysis.
- Recall Level: Level 3 Recall
- Recall Reason: The expiration date printed on the original label of a specific batch of the product accessories is incorrect.
- 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 III recall for several diagnostic products, as reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall, detailed in Medical Device Decision No. 2019-049 and published on March 22, 2019, addresses a critical labeling error. The primary issue identified was the incorrect expiration dates printed on the original labels of specific batches of product accessories. This labeling discrepancy affects a range of essential diagnostic items, including sodium electrode conditioning solutions for electrolyte testing, various calibrators for blood gas, hemoglobin, and electrolyte modules, and multiple quality control products used in blood gas, electrolyte, and biochemical analysis. Under the regulatory oversight of the NMPA, Roche Diagnostics is proactively removing these products from the market to prevent potential issues arising from mislabeled expiration information. The voluntary recall demonstrates the company's commitment to product integrity and patient safety, ensuring that healthcare providers receive accurate product information. Affected parties are directed to refer to the "Medical Device Recall Event Report Form" for comprehensive details on specific models, specifications, and batch numbers involved in this recall.

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