# China NMPA Product Recall - 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/9ab33d10-12a4-4038-9bbb-d19084836277/
Source feed: China

> China NMPA product recall for Multiple quality control products for blood gas, electrolyte and biochemical analysis by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 30, 2020. Recall level: Level 3 Recall. On July 30, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III re

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary recall of several quality control products used in blood gas, electrolyte, and biochemical analysis.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-07-30
- Product Name: Multiple quality control products for blood gas, electrolyte and biochemical analysis
- Recall Level: Level 3 Recall
- Recall Reason: An assembly error occurred during the assembly of the quality control kits, resulting in a very small number of batches of blood gas, electrolyte, and biochemical analysis quality control kits (batch number 21492898) having all test parameters at level 3 that may exceed the detection range.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On July 30, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific quality control products used in blood gas, electrolyte, and biochemical analysis. This action, reported under the National Medical Products Administration (NMPA) framework, stemmed from an internal discovery by Roche Diagnostics regarding an assembly error during the manufacturing process of these quality control kits. The issue affected a small number of batches, specifically batch number 21492898, with serial numbers SN422787 to SN423207. These products were found to have all test parameters at Level 3 potentially exceeding their designated detection range. Roche Diagnostics highlighted that the affected products are equipped with a quality control lockout mechanism. This safeguard either prevents testing or generates immediate alarms for all parameters, effectively alerting operators to the deviation and thereby eliminating potential medical risks to patients and users. The voluntary recall addresses the identified manufacturing discrepancy in adherence to NMPA regulations.

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