China NMPA Product Recall - Microbial analyzer

Beckman Coulter, Inc. initiated a voluntary Class III recall for specific microbiology analyzers due to a significant operational issue. The National Medical Products Administration (NMPA) in China publicized this recall on February 19, 2020, following a report from Beckman Coulter Trading (China) Co., Ltd. The core problem identified was a computer startup failure that occurred after an operating system update on certain models and batches of the microbiology analyzer. This malfunction impacted devices registered under Certificate No. 20192221728, prompting the U.S. manufacturer, Beckman Coulter, Inc., to take corrective action. A Class III recall signifies that the use of or exposure to the product is not likely to cause adverse health consequences, but corrective measures are still necessary to address the identified defect. Detailed information regarding the affected product models, specifications, and batch numbers is available in the