China NMPA Product Recall - Hepatitis C Virus Antibody Detection Reagent (Colloidal Gold Method)

Inco Innovation (Xiamen) Technology Co., Ltd. has initiated a voluntary Class III recall of its Hepatitis C Virus Antibody Detection Reagent (Colloidal Gold Method). This action, announced by the National Medical Products Administration (NMPA) on November 4, 2019, stemmed from national sampling inspections. These inspections determined that specific batches of the diagnostic reagent did not conform to the registered product's technical requirements, as outlined under National Medical Device Registration Certificate No. 20163400853. The non-compliance indicates a failure to meet critical quality or performance standards for the medical device. While the precise models, specifications, and batch numbers affected are detailed in a supplementary Medical Device Recall Event Report Form, the primary issue is the deviation from established regulatory and technical specifications. As a required action, Inco Innovation (Xiamen) Technology Co., Ltd. must facilitate the recall process, ensuring that the non-compliant products are effectively removed from distribution. This recall underscores the NMPA's role in enforcing stringent quality and safety standards for medical devices, thereby protecting public health from potentially deficient products.