China NMPA Product Recall - Creatine kinase assay dry slides (rate method)

Ausendo Medical Device Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Creatine Kinase Assay Dry Tablets (Rate Method), publicly reported by the National Medical Products Administration (NMPA) on April 21, 2019. The company reported the recall event to the Shanghai Food and Drug Administration. The main issue identified was that the VITROS CK dry tablets failed to meet the critical on-machine stability requirement of ≤1 week when used with fully automated biochemical analyzers. This stability non-compliance could potentially affect the accuracy and reliability of diagnostic test results. Under the regulatory framework of the NMPA, the company undertook this voluntary recall action to address the product deficiency. Required actions included the recall of affected product models, specifications, and batches, with detailed information available in a specific Medical Device Recall Event Report Form, ensuring product safety and quality.