China NMPA Product Recall - Staining solutions for blood cell analysis

Mindray Nanjing Biotechnology Co., Ltd. initiated a Class III voluntary recall for its Staining Solution for Hematology Analysis, as reported by the National Medical Products Administration (NMPA) on April 28, 2021. The recall stemmed from internal monitoring of retained product samples, which revealed an abnormal decrease in absorbance at the maximum absorption peak of the staining solution. This issue indicates the product may not meet its technical requirements within its designated shelf life, although no customer complaints or adverse reactions have been reported to date. The affected products are "Staining Solution for Blood Cell Analysis" across two production batches: 2020101704 (610 boxes, Model M-68P FD) and 2020101715 (854 boxes, Model M-68FD). These reagents are crucial for analyzing blood cell morphology and structure, aiding in the diagnosis and monitoring of hematological and infectious diseases. Under the NMPA's regulatory framework, Mindray Nanjing Biotechnology Co., Ltd. has taken immediate corrective actions. The company is actively notifying all customers who received the affected batches and is arranging for free replacement of the non-conforming reagents. This proactive measure ensures patient safety and product quality compliance in accordance with regulatory expectations.