# China NMPA Product Recall - Sample diluent (Etest "TOSOH" II (Cystatin C) STAIA-PACK Cystatin C Sample Diluting Solution)

Source: https://www.globalkeysolutions.net/records/china_product_recall/tosoh-corporation/1c30e35c-e255-4f1f-a3a6-50db4ef8bd25/
Source feed: China

> China NMPA product recall for Sample diluent (Etest "TOSOH" II (Cystatin C) STAIA-PACK Cystatin C Sample Diluting Solution) by Tosoh Corporation published March 18, 2019. Recall level: Level 3 Recall. On February 25, 2019, Tosoh Corporation, the manufacturer, in conjunction with its agent Tosoh (Shan

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Tosoh Corporation voluntarily recalls sample diluent.
- Company Name: Tosoh Corporation
- Publication Date: 2019-03-18
- Product Name: Sample diluent (Etest "TOSOH" II (Cystatin C) STAIA-PACK Cystatin C Sample Diluting Solution)
- Recall Level: Level 3 Recall
- Recall Reason: Our company has discovered that incorrect ingredient concentrations were used in the production of the products in question.
- Discovering Company: Tosoh (Shanghai) Biotechnology Co., Ltd.
- Manufacturing Company: Tosoh Corporation
- Summary: On February 25, 2019, Tosoh Corporation, the manufacturer, in conjunction with its agent Tosoh (Shanghai) Biotechnology Co., Ltd., initiated a voluntary Class III recall of specific batches of its sample diluent. This action was reported to the National Medical Products Administration (NMPA) of China, operating under the regulatory framework for medical devices (National Medical Device Registration Certificate No. 20150422). The primary issue identified was the use of incorrect ingredient content during the manufacturing process of the affected sample diluent batches (195A248 and IZ5A249). Despite this manufacturing discrepancy, internal investigations confirmed that the analytical performance, including dilution capabilities, accuracy, repeatability, and relevance, remained within product specifications. Consequently, the potential for health damage resulting from the use of these products was assessed as extremely low, almost non-existent. A key aspect of this recall is that the affected product batches were not sold or imported into China. Therefore, the required actions within China were limited to the formal reporting of the voluntary recall incident to the NMPA, with no direct corrective measures needed for products within the Chinese market. The recall primarily targeted regions such as Japan, Europe, USA, and Indonesia where the product was distributed. This proactive recall demonstrates the company's commitment to product quality and regulatory compliance even in the absence of a direct safety risk or Chinese market distribution.

Company: https://www.globalkeysolutions.net/companies/tosoh-corporation/bf8db03b-60fc-4624-aaa7-d824ed117f8f/