China NMPA Product Recall - Fully automatic slide pushing and staining system

On October 23, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its fully automated slide-pushing and staining system. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall addresses a critical safety concern stemming from a rare defect: a slight bend in the dispensing needle. This issue occurs if the Sample Aspiration Module (SAM) is not in a safe position during cleaning or troubleshooting. While the system is designed to detect bent probes and generate an error message ("Unable to verify the movement of the stripper motor"), it sometimes fails to detect slight bends. Investigations, prompted by two overseas customer reports, revealed that such undetected slight bends could lead to residual blood from a previous sample remaining at the dispensing path. This poses a significant risk of cross-contamination, as the compromised dispensing probe might contact blood from prior samples when processing new ones. Beckman Coulter is requiring the recall of affected product models and batch numbers, with detailed information provided in an accompanying Medical Device Recall Event Report Form.