China NMPA Product Recall - Gamma-glutamyl transferase assay kit (GGT)

Zhejiang Taiste Biotechnology Co., Ltd. has initiated a voluntary Level III recall for its Gamma-Glutamyl Transferase Assay Kit (GGT) (Registration Certificate No.: Zhexiezhuzhun 20152400880). This action follows a national sampling inspection conducted by the National Medical Products Administration (NMPA) in May 2018. The inspection revealed that the product's linear range deviation did not conform to the filed technical requirements, a critical deviation from regulatory standards. The affected product batch is 20180101-1, produced on January 25, 2018, with an expiry date of January 24, 2019. Of the 84 boxes manufactured, 83 were distributed within China, impacting regions including Changchun, Shenyang, Xi'an, and Lanzhou. While the company assessed no harm resulting from this issue and received no customer complaints, the recall commenced on November 9, 2018, with sales departments notifying all operational and user units. In response, Zhejiang Taiste Biotechnology has ceased shipping the affected batch. The company is actively preparing an application to modify the product's technical requirements to address the identified non-conformance. Furthermore, internal re-testing of retained samples confirmed compliance, suggesting the issue may be related to the initial filing rather than inherent product quality after manufacturing. This recall underscores the regulatory oversight by the NMPA in maintaining product standards within the medical device industry.