China NMPA Product Recall - Sample preservation solution

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its "Sample Preservative Solution" in China, as detailed in an NMPA document published on September 30, 2016. The recall was reported on August 19, 2016, following the company's discovery that a limited number of bottle caps on certain batches of the alcohol-based solution, manufactured by Tripath Imaging, Inc., exhibited cracks. These cracks could lead to the leakage of the preservation solution, which is used for the transportation, preservation, and antibacterial treatment of gynecological samples. The affected product, identified by model/specification 490527 and various batch numbers, was produced or imported in quantities of 3,381,500 bottles globally, with 2,751,000 bottles sold within China. Under the regulatory oversight of the National Medical Products Administration (NMPA), the company is undertaking several corrective actions. These include issuing updated customer letters to inform them of expanded batch numbers, recalling and replacing all affected products from customers, and ensuring the proper destruction of the retrieved solutions. This proactive measure aims to mitigate potential risks associated with compromised product integrity and uphold public health standards.