China NMPA Product Recall - Free thyroxine assay kit (electrochemiluminescence method)

Roche Diagnostics GmbH initiated a Class III voluntary recall of its Free Thyroxine Assay Kit (Electrochemiluminescence Imaging), identified by National Medical Device Registration Certificate 20162404445. The National Medical Products Administration (NMPA) publicly reported this on November 7, 2018, following Roche Diagnostics Products (Shanghai) Co., Ltd.'s report on October 19, 2018. The main issue was a lowered biotin interference threshold in specific batches (e.g., 304692, 331797, 304694, 331807) of the kit. This defect could cause the Free Thyroxine (FT4) recovery rate to vary by over 20% in patient samples containing high concentrations of biotin (≥266 nmol/L or 65 ng/mL). The recall level signifies that the use of, or exposure to, the product is not likely to cause adverse health consequences. While the recall is global, Roche Diagnostics Products (Shanghai) Co., Ltd. confirmed that the affected product batches were not imported or sold within China. Consequently, no direct actions were required for the Chinese market concerning these specific batches, as they were deemed unaffected.