China NMPA Product Recall - Fully Automated Glycated Hemoglobin Analyzer

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.