China NMPA Product Recall - Total thyroxine assay kit (chemiluminescence method) and total thyroxine calibrators

The National Medical Products Administration (NMPA) published an alert regarding the voluntary recall of Total Thyroxine Assay Kits and Total Thyroxine Calibrators. The recall was initiated by the manufacturer, Ortho Clinical Diagnostics (UK), on March 3, 2014, and subsequently reported by its Chinese distributor, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., to the NMPA on March 6, 2014. The primary concern stemmed from potential quality issues with specific product models (1393396 and 8744468) and batch number 1590. Investigations revealed that the affected assay kits could produce test results for quality control products, and potentially patient samples, that were lower than expected. Additionally, calibration failures were reported for the corresponding calibrators from the same batch. This issue could lead to inaccurate diagnostic information for patients. The recall was enacted under the regulatory framework of the NMPA, with directives issued to provincial and municipal food and drug administrations to enhance supervision of such products in China. Ortho Clinical Diagnostics confirmed that its main action for these specific affected products, beyond the recall, was reporting to the State Drug Administration, with no further reports planned.