# China NMPA Product Recall - Fully Automated Glycated Hemoglobin Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/tosoh-co-ltd/8e03dcec-4360-446f-b0d5-9fc46c7e4d07
Source feed: China

> China NMPA product recall for Fully Automated Glycated Hemoglobin Analyzer by Tosoh Co., Ltd. published June 19, 2017. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) published a voluntary Class II recall on June 19

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Tosoh Corporation voluntarily recalls fully automated glycated hemoglobin analyzers
- Company Name: Tosoh Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Fully Automated Glycated Hemoglobin Analyzer
- Recall Level: Level 2 Recall
- Recall Reason: The product in question may produce falsely low test results under certain circumstances, which could affect treatment decisions and lead to long-term complications.
- Discovering Company: Tosoh (Shanghai) Biotechnology Co., Ltd.
- Manufacturing Company: Tosoh Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) published a voluntary Class II recall on June 19, 2017, initiated by Tosoh Corporation, specifically involving Tosoh (Shanghai) Biotechnology Co., Ltd. The recall pertains to their Fully Automated Glycated Hemoglobin Analyzer (Registration No.: CFDA (Imported) No. 20142402004). The core issue identified is that the device has the potential to produce falsely low test results under certain conditions. This malfunction is critical, as inaccurate diagnostic data could significantly impact treatment decisions and potentially lead to adverse long-term complications for patients. While the document does not specify particular inspection dates, it highlights Tosoh Corporation's proactive measure to address this product deficiency. Under the NMPA's regulatory oversight, the company is required to execute this voluntary recall to mitigate the identified health risks. Comprehensive details regarding the affected models, specifications, and batch numbers are provided in the accompanying Medical Device Recall Event Report Form, emphasizing the regulatory commitment to ensuring medical device safety and protecting patient well-being.

Company: https://www.globalkeysolutions.net/companies/tosoh-co-ltd/99163b9b-1fba-48a1-83cb-b7bb866d6598