China NMPA Product Recall - Turbidimeter calibration tube (scattered light turbidimetry)

BD Medical Devices (Shanghai) Co., Ltd., a subsidiary of Becton, Dickinson and Company, initiated a voluntary Class III medical device recall for its Turbidimeter Calibration Tubes (Scattered Light Turbidimetry). This recall was reported on June 8, 2016, and publicly announced by the National Medical Products Administration (NMPA) on August 29, 2016. The primary issue involved an incorrect expiration date printed on the packaging labels of affected product batch number 5345796. The labels erroneously displayed an expiration date of 2018/10/30, instead of the correct 2016/10/30. While individual calibrator vials within the kits showed the correct date, their legibility was poor. The company clarified that, as the products were still within their actual shelf life, no public health risk was identified. This global recall, affecting regions including China, Europe, North and South America, and Asia, was undertaken as a measure of social responsibility to ensure clear customer communication. Required actions included sending written customer letters to inform them of the discrepancy and facilitating the recall and replacement of the affected products.