China NMPA Product Recall - Fully automated immunoassay analyzer

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Fully Automated Immunoassay Analyzer, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. The company identified a critical issue with a circuit board responsible for motor control within the analyzer. This defect could potentially impair the normal operation and movement of the sampling needle and incubation belt during instrument use. This proactive recall by Beckman Coulter aims to address the potential functional anomaly to ensure product safety and reliability. The NMPA serves as the overseeing regulatory body for medical devices in China, under whose purview this recall falls. While the document does not detail specific inspection dates, the company voluntarily reported the issue. As part of the required actions, Beckman Coulter is recalling all affected products. Consumers and healthcare providers are directed to the "Medical Device Recall Event Report Form" for comprehensive details regarding the specific models, specifications, and batch numbers implicated in this recall. This ensures all relevant parties can identify and appropriately manage affected analyzers, mitigating any potential risks associated with the identified circuit board malfunction.