China NMPA Product Recall - autoSCAN®-4 System Microbial Analyzer

On November 14, 2022, the National Medical Products Administration (NMPA) issued a notification regarding a voluntary Class III recall initiated by Beckman Coulter, Inc., for its AutoSCAN®-4 System Microbiology Analyzer. This recall was reported to the NMPA by Beckman Coulter Trading (China) Co., Ltd. The company's decision to recall the device stems from identified production and installation errors that affect specific models and batches of the microbiology analyzer. These errors represent a quality control issue that could potentially impact the device's intended performance or reliability. A Class III recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Beckman Coulter, Inc. is undertaking this voluntary action as a corrective measure to address the identified manufacturing discrepancies and uphold product standards. The comprehensive details concerning the exact affected product models, specifications, and batch numbers are documented in the 'Medical Device Recall Event Report Form' attached to the NMPA's announcement. This regulatory action highlights the NMPA's role in overseeing the safety and quality of medical devices within China and ensures that manufacturers address product deficiencies proactively.