China NMPA Product Recall - Hemolysin for blood cell analysis

Mindray Nanjing Biotechnology Co., Ltd. initiated a voluntary Class III recall on August 21, 2017, for multiple batches of its hemolysing agents used in hematology analysis. The main issue identified was a printing error on the product labels and instruction manuals, where the "Production Date" was omitted. This non-compliance with relevant regulations prompted the recall, although the company confirmed that the absence of this information did not affect product performance or normal customer use, as expiration dates were clearly indicated. The affected products include various packaging specifications for agents registered under Suning Medical Device Filing numbers, such as 20140003, and were distributed across China, involving substantial quantities like over 98,000 boxes of M-3CFL. As part of the required actions, Mindray Nanjing Biotechnology Co., Ltd. is notifying all affected customers via official letters. These communications will detail the labeling discrepancy and provide clear instructions on how to identify the product's production date from the reagent batch number. This recall focuses solely on informational correction and does not necessitate the return of any sold products, as their usability and performance remain unaffected. The actions are in compliance with the regulatory oversight of the Provincial Food and Drug Administration.