China NMPA Product Recall - Fully automated sample processing system

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its DxA 5000 fully automated sample processing system, as reported by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration on June 30, 2020. The recall addresses a critical design limitation where the system's instructions for use and functionality may cause confusion regarding the reuse of sample IDs. The primary issue arises because the DxA 5000 cannot distinguish between reprocessing an existing sample and processing a new sample assigned an ID that was previously used for a different sample. This flaw can lead to samples not being detected by the system, particularly when a new sample with a recycled barcode is introduced after the original sample with that same ID has been removed. While the system can identify duplicate IDs if present simultaneously, its inability to differentiate between these distinct scenarios presents a risk for accurate sample processing. The company's action requires the recall of affected units to mitigate potential operational errors and maintain diagnostic integrity.