China NMPA Product Recall - Fully Automated Slide Pushing and Staining System / Blood Analyzer

Beckman Coulter Trading (China) Co., Ltd., on behalf of Beckman Coulter, Inc., initiated a voluntary Class II recall for its Fully Automated Slide Pushing and Staining Systems and connected Blood Analyzers. This recall was reported on October 25, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 7, 2016. The recall was prompted by confirmed reports of methanol combustion incidents in user-end slide dyeing machines, identified as being caused by a significant increase in the automatic filling frequency of the methanol tank. The issue potentially extends to connected blood analyzers, with the full root cause still under investigation. Affected products include all versions globally, with 20 units sold or imported to China. As corrective actions, Beckman Coulter notified affected customers via letters and direct communication regarding the potential risks. The company also released an upgrade (MOD) for the slide dyeing system, which is being implemented for existing users, and plans a software correction for blood analyzer version 3.0.2.0. Beckman Coulter Trading (China) Co., Ltd. will provide monthly progress reports to the Shanghai Drug Administration.