China NMPA Product Recall - Hemolysin for blood cell analysis

Mindray Nanjing Biotechnology Co., Ltd. initiated a Class III voluntary recall of various hemolysing agents for hematology analysis, as published by the National Medical Products Administration (NMPA) on August 28, 2017, with the company report dated August 21, 2017. The primary issue identified was a labeling and instruction manual error: certain batches of products omitted the "Production Date:" from their design templates. Although the expiration date was clearly marked and product performance or customer use was not affected, this constituted non-compliance with relevant regulatory requirements. In response, Mindray Nanjing Biotechnology Co., Ltd. is undertaking corrective actions. These actions include notifying all affected customers through a formal letter. This communication will inform them about the labeling discrepancy and provide instructions on how to ascertain the manufacturing date using the reagent batch number. The company emphasized that this recall addresses a regulatory non-conformity rather than a safety defect, confirming that all affected products are safe for continued use and no physical return of sold products is involved. This action highlights the importance of accurate and complete labeling in medical device manufacturing under NMPA oversight.