China NMPA Product Recall - Sample processing system

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its ACCELERATOR a3600 sample processing system, as communicated by the National Medical Products Administration (NMPA) on July 24, 2020. This action stems from an urgent field safety update received from Inpeco, the system's manufacturer. The core issue affects aliquot cup modules with specific older firmware versions (AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, and AQMb_3-1-1-8.H86). When a clot detection error occurs during sample aspiration from the original tube, the system erroneously allocates the aspirated sample to the first empty aliquot cup, marking it with "error 2132." The current error message instructs manual handling but lacks critical information regarding potential dilution of these cups by distilled water within the module's hydraulic circulation line. This ambiguity could lead to inaccurate sample analysis. Affected customers in China, particularly those who have configured aliquot cup modules and previously implemented software upgrades as per "Shanghai Drug Administration Medical Device Recall 2020-076," are impacted. The recall signifies the company's commitment to addressing this product safety concern under NMPA oversight, with detailed information on affected products provided in a recall event report.