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

Ausendo Medical Devices Trading (China) Co., Ltd., in coordination with Ortho-Clinical Diagnostics Trading (China) Co., Ltd., initiated a voluntary recall of their Sodium Ion Determination Dry Strips (Direct Electrode Method). This action, reported on January 12, 2017, and published by the National Medical Products Administration (NMPA) on March 1, 2017, addresses a significant product performance issue. The core problem identified is that the Sodium Ion Assay Tablets, registered under certificate number 20152402860, can yield biased measurement results. This occurs if the dry strips are not warmed at room temperature for a minimum of eight hours before being placed on a VITROS analyzer. The recall impacts all batches, with 123,110 boxes imported into China and 110,756 boxes already sold. These strips are critical for quantitatively determining sodium ion content in serum, plasma, and urine samples. Under the NMPA's regulatory framework, the company has implemented several corrective actions globally. Customers are being notified of the issue. Furthermore, they are instructed to ensure all unopened, refrigerated, or frozen dry strips are reconditioned at room temperature (18-28℃/64-82℉) for at least eight hours prior to use. Crucially, customers must recalibrate their VITROS analyzers as soon as possible with properly warmed strips to prevent inaccurate readings. Failure to adhere to these warming and recalibration procedures could lead to continued biased results.