China NMPA Product Recall - Estradiol Assay Kit (Chemiluminescent Immunoassay)

The National Medical Products Administration (NMPA) published a Class II voluntary recall on December 7, 2016, initiated by Sulling Diagnostics Medical Devices (Shanghai) Co., Ltd. This action addresses a significant issue with their Estradiol Assay Kit (Chemiluminescent Immunoassay). The company, which reported the issue on September 2, 2016, discovered that the kit can produce falsely elevated estradiol test results in patients undergoing treatment with fulvestrant (Faslodex®). This inaccuracy stems from fulvestrant's structural similarity to estradiol, causing an unintended cross-reaction with the immunoassay reagents. The affected products include specific batches of the Estradiol Assay Kit (Catalog No. 310680-CN), with 823 kits imported to China. In response, Sulling Diagnostics Medical Devices (Shanghai) Co., Ltd. is undertaking several corrective actions. These include sending notification letters to all affected customers, adding temporary warnings directly to the kits, and amending the official product instruction manual to permanently incorporate this crucial information. Despite the issue, the kit remains usable once these warnings and manual updates are in place, emphasizing cautious interpretation for patients on fulvestrant.