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

Abbott Trading (Shanghai) Co., Ltd., acting as the agent for Abbott Laboratories, initiated a voluntary Class III recall for its Thyroxine Binding Ability Assay Kit (Chemiluminescent Microparticle Immunoassay). This action was reported to the National Medical Products Administration (NMPA) on June 27, 2017, with public notification on July 18, 2017. The recall was necessary due to the potential for affected units of the assay kit to experience calibration failure or curve validity check failure. This issue could compromise the accuracy of in vitro quantitative determination of thyroxine (T4) in human serum or plasma, thereby impacting diagnostic reliability. The affected product, identified by Registration No. 20162404544 and available in 1x100 tests/box and 4x100 tests/box configurations, was subject to this global recall. Despite the recall's global scope, the report indicated zero affected product units were sold within China. Under the NMPA regulatory framework, Abbott Trading (Shanghai) Co., Ltd.'s required action was to voluntarily remove these potentially faulty assay kits from circulation. This proactive measure aims to mitigate risks associated with inaccurate test results and uphold product quality and patient safety standards.