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

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary recall of its Sodium Ion Determination Dry Strips (Direct Electrode Method), as announced by the National Medical Products Administration (NMPA) on February 21, 2017. The recall was prompted by the company's discovery that the product's measurement results would deviate if the rewarming time at room temperature was less than eight hours. This performance issue raised concerns about the accuracy and reliability of the medical device. As a required action under the NMPA's regulatory framework, Ausendo Medical Devices Trading (China) Co., Ltd. decided to recall the affected products. Detailed information regarding the specific models, specifications, and batches involved in this recall was provided in a "Medical Device Recall Event Report Form," indicating a structured approach to addressing the identified product non-conformity and ensuring patient safety. The company proactively reported the issue and took the necessary steps to remove the potentially flawed products from the market.