China NMPA Product Recall - Progesterone receptor assay kit (immunohistochemical method)

GeneTech (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its "Progesterone Receptor Detection Kit (Immunohistochemical Method)." This action was publicly announced on May 8, 2021, under the regulatory oversight of the National Medical Products Administration (NMPA) of China. The core issue leading to the recall was a significant deviation in the kit's formulation. GeneTech reported that the product utilized ProClin 950 as an antibacterial agent, contrary to the original specification in its registered appendix, which stipulated sodium azide. This discrepancy between the approved documentation and the manufactured product necessitated immediate corrective measures. As a required action under the NMPA's framework, GeneTech (Shanghai) Co., Ltd. is conducting a voluntary recall of all affected batches of the detection kit. The Class III classification indicates that while the product deviates from standards, its use or exposure is not expected to cause adverse health consequences. Specific details regarding the recalled product models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form, ensuring transparency and adherence to regulatory compliance.