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. The recall, reported to the National Medical Products Administration (NMPA) on June 5, 2019, stemmed from a labeling discrepancy. The company discovered that some reagent kit labels and instructions, particularly for batch number 2018110200 affecting 86 boxes sold in China, displayed incorrect registration certificate numbers. This error occurred during a transition period following a renewal of the product's registration certificate, leading to outdated numbers being printed.

Despite the labeling issue, Shenzhen Mindray confirmed that the intrinsic quality of the calibrator and its diagnostic test results remain unaffected. The company explicitly stated that this issue poses no clinical risk to patients or operators, thereby justifying the Level III recall, which is typically for situations where the probability of adverse health consequences is remote.

In response, Shenzhen Mindray has undertaken several corrective measures. These include sending notification letters to all affected customers to inform them of the discrepancy. Crucially, users currently utilizing the affected reagents are advised that they can continue normal use due to the absence of impact on product quality or safety. Furthermore, company personnel will directly contact affected customers to facilitate the replacement of the reagents with correctly labeled versions. This proactive approach ensures regulatory compliance under the NMPA framework while prioritizing customer information and product integrity.