China NMPA Product Recall - Human thyroid-stimulating hormone calibrators, ferritin calibrators, follicle-stimulating hormone calibrators, thyroglobulin antibody assay kits (chemiluminescence method), staining solutions for blood cell analysis

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall of several medical devices, as reported to the National Medical Products Administration (NMPA) on June 26, 2017, and published on August 8, 2017. This recall was not a result of an inspection but rather a company-identified issue. The main violation involved incorrect registration certificate information on the Chinese labels of the affected products, which was inconsistent with approvals from the State Food and Drug Administration. The products subject to recall include Human Thyroid Stimulating Hormone Calibrators, Ferritin Calibrators, Follicle Stimulating Hormone Calibrators, Globulin Antibody Assay Kits (Chemiluminescence Method), and Staining Solutions for Hematology Analysis. A total of 22,207 boxes across five product numbers and nine batch numbers were affected in China. In response, Beckman Coulter took immediate corrective actions. They notified all relevant customers through official letters. All existing inventory of affected products was relabeled with the correct registration certificate information. Subsequently, these correctly labeled products were shipped to clients. The company is mandated to submit a comprehensive summary report of these corrective actions to the Shanghai Municipal Food and Drug Administration once the relabeling process is complete for all affected items.