China NMPA Product Recall - Disposable virus sampling tubes

Jiangsu Innova Medical Technology Co., Ltd. has initiated a Level III voluntary recall of its single-use virus sampling tubes, as reported by the National Medical Products Administration (NMPA) on January 20, 2022. The recall stems from customer feedback indicating that the preservation solution within specific batches (e.g., 2210820) exceeded technical pH requirements (6.8-7.6). While sampling swabs were found to be compliant and retained samples met specifications, it is inferred that improper transportation may have caused the preservation solution's pH values to deviate, impacting product performance. The recall affects products distributed within China. In response, Jiangsu Innova Medical Technology Co., Ltd. is undertaking several corrective actions. These include proactively contacting distributors and users to retrieve the affected product batch. The company is also committed to strengthening its production quality management and enhancing product quality testing to ensure future compliance with technical standards. Furthermore, it will immediately investigate any factors that could lead to a recurrence of this issue and implement educational and disciplinary measures for relevant production and responsible personnel. This comprehensive recall aims to ensure product integrity and adherence to company standards.