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

Sulling Diagnostics Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Estradiol Assay Kit (Chemiluminescent Immunoassay), as reported to the National Medical Products Administration (NMPA) on September 2, 2016. The recall was prompted by the discovery that the kit can yield falsely elevated estradiol test results in patients undergoing fulvestrant (Faslodex®) treatment. This issue arises from fulvestrant's structural similarity to estradiol, leading to cross-reactivity with the immunoassay reagents. The affected product, Catalog No. 310680-CN, includes specific batches such as 133112A, with 1178 kits imported into China and 323 kits sold. Required actions involve distributing notification letters to all affected customers, adding immediate warning instructions to the kits, and subsequently revising the product instruction manual to include a clear description of this potential interference. The NMPA has allowed the continued use of the Estradiol Assay Kit, provided these critical warnings and revised instructions are implemented to mitigate patient risk.