China NMPA Product Recall - Sodium ion determination dry plate (direct electrode method)

The National Medical Products Administration (NMPA) published a voluntary recall notice on February 21, 2017, initiated by Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnostics, Inc. The recall involves Sodium Ion Determination Dry Strips (Direct Electrode Method), registered under certificate number 20152402860. The primary issue identified is that the product may yield biased sodium ion measurement results if its rewarming time at room temperature is less than eight hours before being placed on an analyzer. This deviation impacts the product's performance within its 10-day on-board shelf life. A significant quantity of the affected product, 110,756 boxes, was sold in China out of 123,110 boxes imported. Under the NMPA's regulatory oversight, Ortho-Clinical Diagnostics Trading (China) Co., Ltd. has outlined several required actions. These include notifying all affected customers about the issue. Furthermore, customers are instructed to ensure that all unopened refrigerated or frozen dry strips are warmed at room temperature (18-280C/64-820F) for a minimum of eight hours prior to use. Crucially, customers must recalibrate their VITROS analyzers promptly using properly rewarmed strips to prevent biased results, thereby ensuring accurate diagnostic measurements.