China NMPA Product Recall - Estrogen receptor antibody reagent (immunohistochemistry)

GeneTech (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Estrogen Receptor Antibody Reagent (Immunohistochemical Method) on May 8, 2021, as reported by the National Medical Products Administration (NMPA) and the Shanghai Drug Administration. The core issue identified was the unauthorized substitution of an antibacterial agent within the diagnostic kit. Specifically, the company used ProClin 950 instead of sodium azide, which was the antibacterial agent stipulated in the original product appendix. This deviation from the registered formulation prompted the recall. While specific inspection dates are not detailed, the recall announcement itself serves as a regulatory action initiated by the company under oversight from the relevant Chinese drug administrations. The company is responsible for addressing the non-conforming product and ensuring adherence to its approved registration. Affected product models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form.