China NMPA Product Recall - Total iron binding capacity calibrator, total iron binding capacity assay kit (one-step immunoturbidimetric method)

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Level III recall, reported on June 22, 2016, and published by the National Medical Products Administration (NMPA) on August 30, 2016. The recall involves Total Iron Binding Capacitors and Total Iron Binding Capacitor Assay Kits (Immunoturbidimetric One-Step Method), manufactured by Ortho-Clinical Diagnostics, Inc. The issue stemmed from an error value found on the calibration disk of the VITROS Calibration Kit 29. This error specifically affects the VITROS Direct Method Total Iron Binding Capacity (dTIBC) Assay Reagent (Generation 30), causing a positive deviation in patient sample, level solution, and quality control solution measurement results. This could lead to inaccurate diagnostic data. Under NMPA's regulatory oversight, the company's corrective actions include notifying all affected customers. Users are required to install calibration disk version 5884 or later on their VITROS systems. Following this installation, the VITROS Direct Method Total Iron Binding Capacity Assay Reagent (Generation 30) must be recalibrated. Successful calibration and quality control assessment are mandatory before using any remaining affected reagents to ensure accuracy and patient safety.