China NMPA Product Recall - Fully automated immunoassay analyzer

On June 19, 2017, the National Medical Products Administration (NMPA) issued a notice regarding a voluntary Class II recall initiated by Tosoh Corporation. Specifically, Tosoh (Shanghai) Biotechnology Co., Ltd. reported the issue, prompting the recall of Tosoh Corporation's fully automated immunoassay analyzer (Registration No.: 20153402770). No specific inspection dates were detailed within this recall notification. The primary issue identified was the deterioration of certain sensors within the affected analyzers, which led to instrument malfunction and complete operational failure. This critical defect necessitated the company's action to ensure product safety and reliability. Operating under the regulatory oversight of the NMPA, Tosoh Corporation is undertaking required actions by voluntarily recalling the problematic units. Further specifics regarding the affected product models, specifications, and batch numbers are documented in an accompanying "Medical Device Recall Event Report Form," indicating a structured approach to addressing the identified product deficiency and safeguarding public health.