China NMPA Product Recall - Myoglobin calibrators

On December 14, 2018, Ausendo Medical Device Trading (China) Co., Ltd. announced a voluntary Class III recall of its Myoglobin Calibrators. The company initiated this action due to significant stability issues identified with these diagnostic calibrators. These issues pose a risk of leading to inaccurate test results, specifically by causing calibration failures or producing atypical quality control outcomes even after calibration processes are initially deemed successful. Such malfunctions could potentially compromise the reliability of medical diagnostic procedures where myoglobin calibrators are utilized. The recall operates under the oversight of the National Medical Products Administration (NMPA), as documented by Index No. JGXX-2018-11473. The affected products are identifiable through their registration under Shanghai Food and Drug Administration Medical Device Registration Certificate No. 2018-304 and Registration Certificate No. 20152403221. Ausendo Medical Device Trading (China) Co., Ltd. is actively working to remove all impacted batches from the market. Comprehensive details regarding the specific models, specifications, and batch numbers of the affected products are provided in an accompanying "Medical Device Recall Event Report Form." This decisive measure underscores the company's commitment to product quality and patient safety within the regulatory framework governing medical devices.