China NMPA Product Recall - Leukocyte differentiation antigen CD3/CD4/CD45 detection kit (flow cytometry - FITC/PE/PerCP)

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its Leukocyte Differentiation Antigen CD3/CD4/CD45 Detection Kit. The recall, reported to the National Medical Products Administration (NMPA) in July 2016 and published in September 2016, concerned an English labeling error on affected product batches, including 49983 and 54689. The label incorrectly stated "gelatin" instead of "contains buffer." This issue impacted 1,689 boxes globally, with 1,510 boxes distributed in China. The company confirmed that despite the labeling discrepancy, the product's performance and safety are not compromised, as the buffer contains a stabilizer equivalent to gelatin. Under the NMPA's regulatory framework, no product return or replacement is required, and the product can continue to be sold and used. The primary required action is to send a written letter to customers to inform them of the labeling clarification, emphasizing that the recall addresses a labeling inaccuracy rather than a product defect.