China NMPA Product Recall - DxH Fully Automated Slide Pushing and Staining System, DxH 600 Blood Analyzer, DxH 800 Blood Analyzer

Beckman Coulter, Inc., through its subsidiary Beckman Coulter Trading (China) Co., Ltd., initiated a voluntary Class III recall for its DxH Fully Automated Slide Preparation and Staining System and DxH series Blood Analyzers. This action, documented under National Medical Products Administration (NMPA) index JGXX-2018-10084 and reported on January 10, 2018 (with the recall event report dated November 15, 2017), addressed a critical safety concern. The main issue stemmed from a protective cover on the manual sample entry stage of the DxH instruments, which could mechanically interfere with the sampling needle. Specifically, this interference at the right (green) position of the single-tube injection workstation might cause the tube holder to remain descended during aspiration and then eject, leading to a tilted, opened tube. This malfunction posed a risk of biohazardous blood spillage. Although 19 DxH instruments were identified with the problematic cover, the affected batches were not sold in China. Therefore, under the NMPA regulatory framework, the required actions for the Chinese market were deemed "Not Applicable" for these particular recalled products, as no domestic sales necessitated direct corrective measures within China for the identified units.