China NMPA Product Recall - Real-time quantitative PCR amplification instrument

Bio-Rad Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its real-time quantitative PCR amplification instruments. This significant action, publicly reported on March 30, 2020, involved oversight from both the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The primary issue prompting the recall was the discovery that certain units of these medical devices were distributed without the required Chinese instruction manuals. The absence of comprehensive user documentation in the local language constitutes a critical regulatory non-compliance for medical products sold within China, potentially affecting proper use and safety. Following an internal investigation, Bio-Rad Medical Products (Shanghai) Co., Ltd. proactively decided to recall the affected instruments, which are identified by Registration Certificate No. 20193220316. A Class III recall signifies that while the product issue is not expected to cause serious adverse health consequences, it still necessitates corrective measures to maintain regulatory standards. The company's voluntary action demonstrates its commitment to addressing the identified deficiency and ensuring that all distributed products meet the stipulated regulatory requirements for product information and user guidance. Further specific details, including affected product models, specifications, and batch numbers, are provided in the "Medical Device Recall Event Report Form" for stakeholders to access, highlighting transparency in the recall process managed under the NMPA's regulatory framework.