China NMPA Product Recall - Leukocyte differentiation antigen CD4 detection kit (flow cytometry - FITC)

BD Medical Devices (Shanghai) Co., Ltd., a division of Becton, Dickinson and Company, initiated a voluntary Class III recall of its Leukocyte Differentiation Antigen CD4 Detection Kit (Flow Cytometry - FITC). Reported to the National Medical Products Administration (NMPA) on September 2, 2015, the recall was prompted by a labeling error on the original product bottle. Specifically, the Spanish description of the product name incorrectly stated "CD8" instead of "CD4." The company confirmed that this was a typographical error limited to the bottle label, with the outer packaging and accompanying instructions being accurate. Importantly, the product itself had no quality issues and posed no safety or diagnostic risk to patients. The company reported that 23 affected units, identified by Item Number 340133 and Batch Number 5112711, were imported but remained unsold within China. Consequently, all affected inventory has been sealed and is slated for destruction. As no products were distributed or sold, BD Medical Devices (Shanghai) Co., Ltd. will not be issuing customer letters or recall confirmation forms.