China NMPA Product Recall - Thyroxine binding capacity calibrator

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Abbott Laboratories regarding its Thyroxine Binding Ability Calibrators. Abbott Trading (Shanghai) Co., Ltd. reported stability issues with specific product batches (614719, 650124, 697989), which possess registration certificate number CFDA (Imported) 2013 No. 2404850. These calibrators are intended for use with the ARCHITECTI system to quantify total thyroxine binding power in human serum or plasma. The primary issue identified was a stability problem that could lead to quality control samples exceeding their specified ranges. Abbott Laboratories reported this voluntary recall on March 7, 2016, with the NMPA publishing the notice on April 13, 2016. A key finding was that the affected batches were not sold or imported into China. Therefore, Abbott Diagnostics was not required to take corrective actions within the Chinese market. However, the NMPA directed all provincial food and drug administrations to reinforce their supervision and management over similar medical products.