China NMPA Product Recall - Sample preservation solution

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Sample Preservative Solution, model 490527. The recall stemmed from a quality issue discovered by the company's U.S. headquarters, where a small percentage of bottle caps were found to have cracks, potentially causing the preservation solution to leak. This defect impacts 1,875,500 bottles produced or imported, with 1,270,500 bottles sold within the Chinese market. The company reported this issue on February 19, 2016, leading to a public announcement by the National Medical Products Administration (NMPA) on April 21, 2016. This action falls under the NMPA's regulatory framework for medical device oversight, addressing concerns for a product used in the transportation and preservation of gynecological samples. Required actions include sending written notifications to all affected customers to inform them of the incident and facilitating the recall and replacement of all affected products to ensure product quality and customer safety.