China NMPA Product Recall - Sodium ion determination using a thousand-piece sample (direct electrode method)

The National Medical Products Administration (NMPA) published details of a voluntary recall initiated by Ausendo Medical Devices Trading (China) Co., Ltd. regarding Sodium Ion Assay Dry Strips (Direct Electrode Method). The product's manufacturer is Ortho-Clinical Diagnostics, Inc., with its local Chinese entity being Ortho-Clinical Medical Devices Trading (China) Co., Ltd. The company submitted its recall report on January 12, 2017, with the NMPA publicizing the information on February 21, 2017.The primary issue identified was that the sodium ion assay dry strips could yield biased measurement results if not allowed to warm to room temperature for a minimum of eight hours before being placed on an analyzer. This critical rewarming period is essential for accurate performance throughout the 10-day on-board storage duration. Approximately 123,110 boxes were imported into China, with 110,756 boxes of the affected product sold domestically.Under the NMPA's regulatory framework, specific corrective actions are required. All affected customers must be notified. Unopened strips, previously refrigerated or frozen, must be stored at room temperature (18-28°C) for at least eight hours before use. Additionally, customers are mandated to promptly recalibrate each VITROS analyzer using a properly warmed sodium ion assay dry strip to prevent potentially inaccurate diagnostic results.