China NMPA Product Recall - Gamma-glutamyl transferase assay kit (continuous monitoring method)

Zhejiang Fukang Biotechnology Co., Ltd. initiated a voluntary Class III recall of its -Glutamyl Transferase Assay Kit (Continuous Monitoring Method) on January 17, 2019. This action followed the product's failure in a national medical device supervision and spot check conducted by the National Medical Products Administration (NMPA), indicating the kit was substandard. The specific batch identified as failing was 20180315, affecting models R1 (60*2) and R2 (15*2).Upon receiving the report of the product's non-conformance, Zhejiang Fukang Biotechnology Co., Ltd. promptly implemented corrective actions. These included immediately recalling all sold units of the compromised batch. During the recall process, it was determined that five boxes of the R2 model kits had already been consumed, while 12 boxes of the R1 model were successfully sealed to prevent further use. Furthermore, as a proactive measure, the company re-sampled and tested other batches of the same product within their expiration dates, confirming their adherence to quality standards. This recall highlights the NMPA's regulatory oversight in ensuring the quality and safety of medical devices in the market.