China NMPA Product Recall - Fully automated biochemical analyzer

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its fully automated biochemical analyzer (ADVIA Chemistry XPT system, software version V1.4) on May 21, 2021. This action was taken under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The core issue stems from a potential inconsistency in the instrument's performance regarding the default mixing fault detection setting, '2: Alarm + Stop,' for its Reagent 1 and Reagent 2 mixer components. This anomaly could result in the reporting of falsely elevated or decreased patient results without an alarm notification, impacting diagnostic accuracy. Siemens clarified that users who have configured their instruments with alternative mixing validation settings—'0: Ignore,' '1: Alarm,' or '3: Alarm + Wait'—are not affected by this particular problem. The required action involves the voluntary recall of the affected devices to address this software performance discrepancy, with further details on specific product models and batch numbers provided in the Medical Device Recall Event Report Form.