China NMPA Product Recall - ∝-Hydroxybutyrate dehydrogenase assay kit (rate method)

Chongqing Zhongyuan Biotechnology Co., Ltd. initiated a voluntary Level III recall for its ∝-Hydroxybutyrate Dehydrogenase Detection Kit (Rate Method), specifically Batch No. Z170301 with specifications R1 48mL×2 and R2 12mL×2. The company took this action because internal product testing revealed that items within this batch did not meet the established registered product standard requirements, indicating a significant quality deviation. This recall was formally reported on September 27, 2017, and subsequently publicized by the National Medical Products Administration (NMPA) on September 29, 2017. While specific inspection dates are not detailed, the prompt recall reflects the company's response to its quality control findings. Under the regulatory oversight of the NMPA, Chongqing Zhongyuan Biotechnology Co., Ltd. is required to manage the retrieval and proper handling of all affected kits from the market to ensure public safety and adherence to product standards.