China NMPA Product Recall - Hepatitis B surface antigen calibrator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a Level III voluntary recall for specific batches of its Hepatitis B surface antigen calibrators. This recall was reported to the National Medical Products Administration (NMPA) on June 5, 2019, with public notification on June 6, 2019. The primary issue identified was incorrect registration certificate numbers appearing on the reagent kit labels and instructions for batch number 2018110200. This discrepancy occurred due to a change in the registration certificate number during the product's renewal process, resulting in some labels and instructions being printed with outdated information. Shenzhen Mindray confirmed that this labeling error does not compromise the intrinsic quality of the reagent, nor does it affect diagnostic test results, posing no clinical risk to patients or operators. As part of its corrective actions, Shenzhen Mindray is notifying all affected customers and will replace the reagents. However, users are advised that they can continue to use their currently held reagents normally, as the product's quality and performance remain unaffected.