China NMPA Product Recall - Total iron binding strength sample pretreatment column kit

Beckman Coulter Trading (China) Co., Ltd. initiated a Level III voluntary recall for its Total Iron Binding Capacity Sample Pretreatment Column Kit. The recall, reported on October 25, 2016, and published by the National Medical Products Administration (NMPA) on December 7, 2016, stemmed from an inconsistency in storage temperature instructions. The company discovered that the Chinese registration certificate, instructions, and product label incorrectly indicated refrigeration, while the product no longer required such storage, and its English label correctly specified room temperature. This discrepancy arose after the kit components were repackaged, and the change was not synchronized across all Chinese regulatory documents due to the registration process. The affected products include all batch numbers of the kit, with 3,179 units sold in China. To address the issue under the NMPA's regulatory framework, Beckman Coulter is updating the Chinese registration certificate for storage temperature, notifying affected customers, relabeling all inventory products with correct storage information, and will submit a summary report to the Shanghai Municipal Drug Administration after completing these actions.