China NMPA Product Recall - Thyroxine binding affinity assay kit (chemiluminescent microparticle immunoassay)

Abbott Trading (Shanghai) Co., Ltd., as the agent for manufacturer Abbott Laboratories, filed a voluntary recall report with the National Medical Products Administration (NMPA) on July 19, 2017. The report pertains to the Thyroxine Binding Ability Assay Kit (Chemiluminescent Microparticle Immunoassay), identified by National Medical Device Registration Certificate 20162404544. The core issue involves affected units potentially experiencing calibration failure or curve validity check failure, which could compromise the accuracy of in vitro thyroxine measurements. This global Class III voluntary recall was initiated due to this potential diagnostic reliability concern. However, Abbott Trading (Shanghai) Co., Ltd. confirmed that no affected products were sold or distributed within the Chinese market. Consequently, while the global issue is acknowledged and reported to the NMPA under the regulatory framework, no specific domestic corrective actions, such as product retrieval, are required within China for consumers or healthcare providers. The report was submitted by Liu Wenxia on June 27, 2017.