China NMPA Product Recall - Fully automated sample processing system

Beckman Coulter Biomedical GmbH initiated a voluntary Class III recall for its Fully Automated Sample Processing System, model DxA 5000, as reported to China's National Medical Products Administration (NMPA) on January 28, 2019. This recall addresses critical software-related issues impacting sample processing accuracy and efficiency. Two primary concerns were identified. First, the DxA 5000 system's Liquid Level Detection (LLD) function, when set for automatic centrifugation detection, sometimes failed to distinguish between centrifuged and uncentrifuged samples. This could result in unsuitable samples being processed by connected analyzers, potentially leading to inaccurate test results. Second, a separate software defect prevented samples from transferring out of the buffer, causing delays in processing, extended turnaround times, or even sample expiration. Both issues carry the risk of erroneous analytical outcomes. Beckman Coulter has implemented immediate corrective actions, advising users to utilize system settings and manual checks as temporary mitigation strategies. The company is thoroughly investigating these root causes and commits to releasing a software update to eliminate these risks permanently. It's important to note that the affected DxA 5000 units were not distributed or sold within the Chinese market.