China NMPA Product Recall - Diluent for blood cell analysis

Mindray Nanjing Biotechnology Co., Ltd. voluntarily initiated a Level III recall for several diluents used in hematology analysis, as reported by the National Medical Products Administration (NMPA) on August 21, 2017. The recall stemmed from printing errors on the product labels and instructions for use, specifically the absence of a "Production Date:" field. Despite this labeling non-compliance, the company affirmed that the affected products (models DS, M-3D, M-5D, and M-68DR) were safe, with clear expiration dates provided, and their performance or customer use remained unaffected. As corrective action, Mindray Nanjing Biotechnology Co., Ltd. committed to notifying all impacted customers via a letter. This communication would detail the labeling discrepancy and guide customers on identifying the production date using the reagent batch number. Significantly, the recall did not require the return of any sold products, underscoring that the issue was one of regulatory labeling adherence rather than product safety or efficacy. The recall involved a substantial volume of products distributed within China.