China NMPA Product Recall - Sample processing system

Abbott Trading (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its sample processing system (Registration Certificate No.: 20161009), as reported by the National Medical Products Administration (NMPA) on April 14, 2020, and published on July 6, 2020. The recall stems from two critical issues identified in the system's firmware.

Firstly, specific firmware versions (CM_1-7-0.H86, CM_1-7-1.H86) in the centrifuge modules (Inpeco model FLX-202) contain a tube loading algorithm that does not adhere to balancing instructions. This deficiency can lead to load imbalances, potentially causing a "total timeout error (code 7083)." This error is particularly likely if the ARCHITECT c system interface module is active and the sample turntable lid remains open, or if multiple samples run for extended periods.

Secondly, dispensing modules with older firmware versions (AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, AQMb_3-1-1-8.H86) exhibit a flaw in their clot detection error recovery. If a clot detection error (code EOEO) occurs, the system's procedure for returning sample volume could inadvertently cause distilled water from the hydraulic system to backflow into the original sample tube.

Abbott Trading (Shanghai) Co., Ltd. is taking required action by recalling the affected devices. Further specifics on impacted product models, specifications, and batches are available in the attached "Medical Device Recall Event Report Form." This proactive measure ensures compliance with NMPA regulations and patient safety standards.