China NMPA Product Recall - Fully automated blood cell analyzer

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall of its fully automated hematology analyzer (Registration Certificate No.: 20182220358), as reported on March 6, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stems from internal investigations revealing a critical safety concern: if the instrument's bleaching cycle is interrupted or terminated, the system fails to alert the operator with warning messages. Consequently, the analyzer cannot effectively remove residual bleach before proceeding to analyze patient samples. This deficiency could potentially lead to inaccurate test results or compromise sample integrity due to residual chemical contamination. The company's proactive recall aims to mitigate risks associated with this functional defect, ensuring patient safety and diagnostic reliability. The regulatory framework governing this action includes the NMPA and local food and drug administration bodies, which oversee medical device safety and compliance in China. Required actions involve the immediate voluntary recall of affected product models, specifications, and batches, with further details provided in an accompanying Medical Device Recall Event Report Form. This measure underscores the company's commitment to product quality and adherence to regulatory standards, addressing a significant operational flaw to prevent potential adverse outcomes.