China NMPA Product Recall - Fully automated blood cell analyzer

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated hematology analyzer, model DxH500, as reported on July 5, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stems from an internal investigation revealing a critical software deficiency. Specifically, the DxH500 system fails to alert operators if the Bleach Cycle program is interrupted or terminated. Consequently, the analyzer cannot effectively remove residual bleach before processing patient samples. While the software performs a diluent reset after an interruption, this procedure has been deemed insufficient, posing a risk that the initial sample run could be adversely affected by residual bleach. This issue could lead to inaccurate diagnostic results. In response to this identified risk, Beckman Coulter Trading (China) Co., Ltd. has taken the required action to recall the affected devices, as detailed in the Medical Device Recall Event Report Form. The recall aims to prevent potential diagnostic inaccuracies stemming from the software anomaly.