China NMPA Product Recall - DxH Diluent for Blood Cell Analysis

Beckman Coulter, Inc., in collaboration with its subsidiary Beckman Coulter Trading (China) Co., Ltd., has initiated a voluntary Class III recall for its DxH Diluent used in hematology analysis. This action was reported to the National Medical Products Administration (NMPA) under the regulatory framework governing medical devices, specifically for products registered with National Medical Device Registration No. 20140159.

The core issue identified is that the DxH Diluent, when utilized with UniCel DxH 600, 800, and 900 analyzers, may adversely affect the accuracy of platelet (PLT) and mean platelet volume (MPV) parameters. Such inaccuracies in routine diagnostic tests pose a risk of delaying accurate patient diagnosis and subsequent appropriate treatment.

As the required action, Beckman Coulter, Inc. is voluntarily recalling the product to address these potential risks. It is important to note that, as per the report, the specific recalled products were not imported into China. Further detailed information pertaining to the affected products is available in the 'Medical Device Recall Event Report Form' referenced in the NMPA's announcement.