China NMPA Product Recall - Fully automatic slide pushing and staining system

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated slide dispensing and staining system, manufactured by E. Coulter, Inc. The recall, publicized by the National Medical Products Administration (NMPA) on August 8, 2017, addresses a critical product issue where certain connectors on the system exhibit slow dripping of staining reagents, including formaldehyde, ethanol, or buffer solution, onto the reagent overflow tray. This malfunction could potentially affect the integrity of the staining process or user safety. While specific inspection dates are not provided, the regulatory framework governing this action is the NMPA in China. The required action by Beckman Coulter, Inc. is a voluntary recall to address the identified product defect. Detailed information regarding the affected product models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form" attachment, ensuring transparency and comprehensive resolution of the issue.