China NMPA Product Recall - gamma-glutamyl transferase (GGT) assay kit (IFCC recommended method)

On August 26, 2021, the National Medical Products Administration (NMPA) reported a voluntary Class III recall initiated by Shanghai Juchuang Pharmaceutical Technology Co., Ltd. This recall pertains to their Gamma-Glutamyl Transferase (GGT) Assay Kit, specifically the IFCC Recommended Method. The primary issue prompting this action was a lapse in quality control during the manufacturing process. It was discovered that the filter equipment used for Reagent 1 had exceeded its scheduled cleaning expiration date. Consequently, the filtration efficacy of Reagent 1 failed to meet the stringent product specifications, potentially compromising the kit's performance and reliability. Operating under the oversight of the NMPA, Shanghai Juchuang Pharmaceutical Technology Co., Ltd. proactively decided to retrieve the affected kits from the market. The classification of this as a Class III recall suggests that while there is a potential for adverse health consequences, the probability of serious harm is low, or the consequences are not life-threatening. The company has committed to providing comprehensive details regarding the specific product models, specifications, and batch numbers involved in the recall through a detailed "Medical Device Recall Event Report Form." This voluntary action underscores the manufacturer's responsibility to ensure product quality and patient safety within the regulatory framework established by the NMPA.